Data / Medical devices / United States / Exactech, Inc.
Exactech, Inc.: FDA-registered device maker in Gainesville, FL, United States, 137 510(k) clearances
Exactech, Inc. is registered with the FDA (registration 1038671) in Gainesville, FL, United States. It lists 63 device types. The FDA files 137 510(k) clearances under its listings, the newest dated April 14, 2026. 71 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1038671
- Address
- 2320 N.W. 66TH CT., Gainesville, FL, United States, 32653
- Owner or operator
- EXACTECH, INC. (1038671)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- July 15, 1992
- Registered through
- 2026
- Brand names listed
- 12/14 Alumina Femoral Head, 12/14 Alumina Femoral Heads 36mm, 12/14 Total Hip System, AcuMacth 12/14 Cemented Femrl Stems, AcuMatch 12/14 Press-Fit Femrl Stem, AcuMatch A-Series /MCS Con Ace Linr, AcuMatch A-Series Enhnced Polyethyl, AcuMatch L-Series Bipolar and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 137.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 14, 2026 | K260583 | Equinoxe® Shoulder System | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| June 26, 2025 | K243275 | Equinoxe® Scapula Fracture System | HRS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 10, 2025 | K243839 | Alteon® HA Femoral Stems | MEH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| October 3, 2024 | K240393 | Exactech® TRULIANT® Knee System | MBH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 18, 2024 | K233482 | Equinoxe® Central Screw Baseplate System | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| October 12, 2023 | K230717 | Exactech® Vantage® Total Ankle System | HSN | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 25, 2023 | K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC Screws | HRS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 14, 2023 | K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 11, 2023 | K232002 | Vantage® Total Ankle System | HSN | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 17, 2023 | K223252 | TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 19, 2023 | K221323 | Exactech® Alteon® Short Tapered Wedge | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 4, 2022 | K212356 | Exactech® Equinoxe® Laser Cage Glenoid | KWS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 29, 2020 | K192097 | Exactech® Equinoxe® Stemless Humeral Components | PKC | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 20, 2020 | K193098 | Exactech® Equinoxe® Reverse Shoulder Glenospheres | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| August 20, 2019 | K191561 | Exactech Equinoxe Humeral Augmented Trays | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 1, 2019 | K183343 | Vantage Total Ankle Flat Cut Talar Components | HSN | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 13, 2019 | K182502 | Alteon Acetabular Cup System | LPH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 13, 2019 | K182991 | EPIC Extremity Fusion Plate System | HRS | Substantially Equivalent | Epic Extremity, LLC | accessdata.fda.gov |
| November 26, 2018 | K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | MBH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 8, 2018 | K182462 | Exactech Alteon Highly Polished Femoral Stem | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| October 12, 2018 | K182536 | Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 28, 2018 | K181794 | Truliant Porous Femoral Components | MBH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 4, 2018 | K181532 | Exactech Alteon Monobloc Revision Stem | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 25, 2018 | K180632 | Exactech Equinoxe Small Reverse Shoulder System | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 12, 2018 | K173583 | Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners | OQI | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 9, 2018 | K173388 | Exactech Equinoxe Stemless Shoulder | PKC | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 6, 2017 | K172441 | EPIC Extremity Fracture Plate System | HRS | Substantially Equivalent | Epic Extremity, LLC | accessdata.fda.gov |
| May 16, 2017 | K163226 | EPIC Extremely Small Staple | JDR | Substantially Equivalent | Epic Extremely, LLC | accessdata.fda.gov |
| April 28, 2017 | K171045 | Exactech® Truliant Line Extensions | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 26, 2017 | K162732 | Exactech® Alteon® HA Femoral Stem | MEH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 28, 2017 | K163038 | EPIC Extremity Snap-Off Screw | HWC | Substantially Equivalent | Epic Extremity, LLC | accessdata.fda.gov |
| February 27, 2017 | K162903 | Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies | KWT | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 23, 2017 | K170240 | Truliant Femoral Components | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 1, 2017 | K162726 | Exactech® Equinoxe® Preserve Stem | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| August 31, 2016 | K153649 | Exactech® Novation® Element Press-fit Femoral Stem | MEH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 25, 2016 | K153595 | Optetrak Logic Metaphyseal Cones | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 18, 2016 | K160484 | Optetrak Advanced Patella | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 10, 2016 | K152217 | Exactech Vantage Total Ankle System | HSN | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 9, 2016 | K153340 | Epic Extremity Plate System | HRS | Substantially Equivalent | Epic Extremity, LLC | accessdata.fda.gov |
| January 19, 2016 | K153333 | Epic Extremity Cannulated Screw System | HWC | Substantially Equivalent | Epic Extremity, LLC | accessdata.fda.gov |
| September 3, 2015 | K152170 | Exactech Optetrak Logic Enhanced Assembly | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 3, 2015 | K141960 | Exactech® Novation® Crown Cup® | LPH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 20, 2015 | K150066 | Exactech Alteon Monobloc Revision Stem | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 29, 2015 | K150890 | Exactech Optetrak Logic CC | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 14, 2015 | K150458 | Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 9, 2015 | K143659 | Equinoxe Mega Prosthesis | KWT | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| August 28, 2014 | K141821 | ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 30, 2014 | K140302 | OPTETRAK LOGIC POROUS FEMORAL COMPONENTS | MBH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 29, 2014 | K141797 | ALTEON 6.5MM BONE SCREWS | LPH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| June 30, 2014 | K140674 | EXACTECH TAPERED WEDGE FEMORAL STEM | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 11, 2014 | K140063 | EQUINOXE EXTRA SHORT HUMERAL HEAD | KWS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 26, 2013 | K131298 | EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM | HSD | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| October 11, 2013 | K132161 | OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 3, 2013 | K131575 | EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 20, 2013 | K123687 | OPTETRAK LOGIC POROUS FEMORAL COMPONENT | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| January 16, 2013 | K121392 | NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| January 10, 2013 | K123342 | OPTETRAK LOGIC CRC TIBIAL INSERT | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| December 6, 2012 | K121067 | EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 27, 2012 | K121989 | OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, | MQV | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 20, 2012 | K121220 | EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT | KWS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| October 1, 2012 | K121684 | NOVATION LPI PRIME FEMORAL STEM | LPH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 31, 2012 | K121307 | OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 16, 2012 | K113320 | NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 | MEH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| January 4, 2012 | K113609 | NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 | LPH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| December 8, 2011 | K113309 | EXACTECH EQUINOXE CAGE GLENOIDS | KWS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| August 12, 2011 | K103699 | EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC | NUN | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 28, 2011 | K111400 | OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| June 8, 2011 | K111379 | EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT | KWS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 17, 2011 | K110706 | EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD | KWT | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 14, 2011 | K110547 | OPTERTRAK LOGIC PSC TIBIAL INSERT | JWH | Substantially Equivalent | Exactech Sarasota | accessdata.fda.gov |
| April 1, 2011 | K110708 | EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| December 13, 2010 | K103419 | EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM | KWS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 10, 2010 | K103012 | EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 8, 2010 | K102487 | NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 4, 2010 | K102951 | EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 21, 2010 | K101761 | EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 | LPH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 2, 2010 | K093430 | EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. | KWS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| August 2, 2010 | K101981 | OPTETRAK LOGIC COMBINATION TIBIAL TRAY | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| August 2, 2010 | K101909 | EXACTECH EQUINOXE, PLATFORM FRACTURE STEM | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 27, 2010 | K100269 | NOVATION CROWN CUP GXL LINERS | LPH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 27, 2010 | K093275 | EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 11, 2010 | K093978 | EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM | HRS | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| January 11, 2010 | K093360 | OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| January 7, 2010 | K092900 | EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 21, 2009 | K090764 | NOVATION CFS PRESS-FIT AND CEMENTED STEMS | LWJ | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| December 17, 2008 | K083392 | NOVATION 12/14 CEMENTED FEMORAL STEMS | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| October 10, 2008 | K082702 | EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 2, 2008 | K082022 | OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 6, 2008 | K080980 | EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS | MEH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 29, 2008 | K073688 | EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| August 15, 2007 | K071738 | EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER | JWH | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| July 19, 2007 | K071676 | EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS | KWZ | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| June 7, 2007 | K063685 | OPTECURE; OPTECURE + CCC | MBP | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 15, 2007 | K070479 | EXACTECH NOVATION CROWN CUP AND LINERS | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 23, 2007 | K063569 | EQUINOXE REVERSE SHOULDER SYSTEM | PHX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| November 29, 2006 | K063279 | NOVATION SPLINED RDD FEMORAL STEMS | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| September 12, 2006 | K061668 | OPTECURE +CCC | MBP | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| June 12, 2006 | K061454 | EXACTECH EQUINOXE SHOULDER STEMS | HSD | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 8, 2006 | K050806 | OPTECURE | MBP | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| February 6, 2006 | K060107 | MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS | LZO | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 3, 2026 | 98376 | Class II | Ongoing | Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 | Impactor handle may be missing cross-pin | accessdata.fda.gov |
| September 5, 2025 | 97588 | Class II | Ongoing | Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component | Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria. | accessdata.fda.gov |
| August 15, 2025 | 97459 | Class II | Ongoing | Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/ | Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. | accessdata.fda.gov |
| December 31, 2024 | 96102 | Class II | Ongoing | AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0 LNR G 28MM 140-32-27 AM EHXL 0 LNR G 32MM 140-32-28 AM EHXL 0 LNR H 32MM 140-28-29 AM EHXL 0 LNR J 28MM 140-32-29 AM EHXL 0 LNR J 32MM 140-36-29 AM EHXL | Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer. | accessdata.fda.gov |
| April 26, 2024 | 94410 | Class II | Ongoing | Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25 | The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), Nylon, and EVOH, or 2) LDPE and Nylon without EVOH. | accessdata.fda.gov |
| April 18, 2024 | 94409 | Class II | Ongoing | OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM | Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags. | accessdata.fda.gov |
| March 6, 2024 | 94092 | Class II | Ongoing | Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty | The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH). | accessdata.fda.gov |
| November 21, 2023 | 93507 | Class II | Ongoing | AcuMatch Hip System, Catalog Number 142-32-27 | Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | accessdata.fda.gov |
| June 5, 2023 | 92414 | Class II | Ongoing | Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. | The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction. | accessdata.fda.gov |
| August 11, 2022 | 90279 | Class II | Ongoing | GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG AC | Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear. | accessdata.fda.gov |
| August 30, 2021 | 88570 | Class II | Ongoing | OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK Al | Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. | accessdata.fda.gov |
| June 29, 2021 | 88259 | Class II | Completed | Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component. | Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5). | accessdata.fda.gov |
| June 29, 2021 | 88126 | Class II | Ongoing | Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL Liner 5/15 DEG. Orthopedic hip implant component. | Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning. | accessdata.fda.gov |
| May 11, 2021 | 87989 | Class II | Completed | Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD | The HAT trial contains a retaining ring that has shown the potential to disengage during use. | accessdata.fda.gov |
| November 9, 2020 | 86760 | Class II | Ongoing | Equinoxe Humeral Stem, Primary, Press Fit, 11mm | Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. | accessdata.fda.gov |
| October 6, 2020 | 86630 | Class II | Terminated | Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium | The product may be mislabeled. | accessdata.fda.gov |
| September 25, 2020 | 86590 | Class II | Terminated | Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only. | The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. | accessdata.fda.gov |
| August 24, 2020 | 86396 | Class II | Terminated | Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm. | Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw. | accessdata.fda.gov |
| August 10, 2020 | 86261 | Class II | Ongoing | The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm. | The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 3 when the implant size i | accessdata.fda.gov |
| January 27, 2020 | 84961 | Class II | Ongoing | Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, stems, augments, and surgical instrumenta | These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm. | accessdata.fda.gov |
| December 3, 2019 | 84532 | Class II | Terminated | Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated for use and in skeletally mature individuals with degenerative diseases | Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems. | accessdata.fda.gov |
| October 2, 2019 | 84040 | Class II | Terminated | 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Tot | Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended. | accessdata.fda.gov |
| September 10, 2019 | 83855 | Class II | Terminated | Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is singl | Potential for the wire to fracture at the threads and remain in the glenoid. | accessdata.fda.gov |
| July 24, 2019 | 83520 | Class II | Terminated | Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments a | The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media. | accessdata.fda.gov |
| April 26, 2019 | 82759 | Class II | Terminated | Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30 | The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment. | accessdata.fda.gov |
| March 13, 2019 | 82480 | Class II | Terminated | Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indica | 2.5 Truliant Fit Trays were mismarked as 3 | accessdata.fda.gov |
| December 5, 2018 | 82025 | Class II | Terminated | Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty | Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended. | accessdata.fda.gov |
| August 21, 2018 | 80996 | Class II | Ongoing | Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery | The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended. | accessdata.fda.gov |
| July 13, 2018 | 80667 | Class II | Terminated | Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements. | Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628. | accessdata.fda.gov |
| May 8, 2018 | 80763 | Class II | Ongoing | Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, os | Potentially have non-conforming internal threads. | accessdata.fda.gov |
| October 9, 2017 | 78936 | Class II | Terminated | Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement d | Wrong device description of the label identifying the implant | accessdata.fda.gov |
| September 19, 2017 | 78111 | Class II | Terminated | Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX. | There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray. | accessdata.fda.gov |
| August 31, 2017 | 78903 | Class II | Terminated | Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi | Potentially mislabeled. | accessdata.fda.gov |
| July 11, 2017 | 78064 | Class II | Terminated | Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool | Vix Bit may fracture during use. | accessdata.fda.gov |
| June 23, 2017 | 77592 | Class II | Terminated | Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, s | The Truliant Tibial Trial Handle's pin may disassociate from the main body. | accessdata.fda.gov |
| May 25, 2017 | 77004 | Class II | Terminated | EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01 | Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage. | accessdata.fda.gov |
| May 25, 2017 | 77001 | Class II | Terminated | Logic Fit Tibial Tamp Head | The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade. | accessdata.fda.gov |
| May 22, 2017 | 77002 | Class II | Terminated | Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments | The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied. | accessdata.fda.gov |
| May 16, 2017 | 77479 | Class II | Terminated | Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe rheumatoid, post-traumatic, or degenerative arthritis. It is also indicated fo | Possible inner labeling and packaged device not matching the outer label on the box. | accessdata.fda.gov |
| April 7, 2017 | 77514 | Class II | Terminated | Exactech Optetrak Logic CC 15mm Tibial Augment Screws | Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required. | accessdata.fda.gov |
| November 7, 2016 | 75989 | Class II | Terminated | Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15. | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. | accessdata.fda.gov |
| October 25, 2016 | 75740 | Class II | Terminated | Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit | Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver. | accessdata.fda.gov |
| May 26, 2016 | 74317 | Class II | Terminated | Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replac | Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another. | accessdata.fda.gov |
| April 12, 2016 | 73200 | Class II | Terminated | Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty. | Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. | accessdata.fda.gov |
| September 28, 2015 | 73057 | Class II | Terminated | Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletall | Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One Interbody Fusion Device Parallel (05-090-02-1610) | accessdata.fda.gov |
| September 23, 2015 | 72357 | Class II | Terminated | Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation | Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating. | accessdata.fda.gov |
| May 21, 2015 | 71501 | Class II | Terminated | Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of disco | Shipped to a single consignee prior to completion of final inspection. | accessdata.fda.gov |
| February 13, 2015 | 70722 | Class II | Terminated | Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component. | Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device. | accessdata.fda.gov |
| October 9, 2014 | 69466 | Class II | Terminated | Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants | Mislabeled | accessdata.fda.gov |
| March 7, 2014 | 68341 | Class II | Terminated | NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement. | The femoral stem is lacking specified plasma coating. | accessdata.fda.gov |
| January 6, 2014 | 67486 | Class II | Terminated | Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with d | The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy. | accessdata.fda.gov |
| September 11, 2013 | 67215 | Class II | Terminated | REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature indiv | Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard. | accessdata.fda.gov |
| May 30, 2013 | 65568 | Class II | Terminated | Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. | When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the instrument. | accessdata.fda.gov |
| February 1, 2013 | 64465 | Class II | Terminated | Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508. | A dimensional mismatch was identified which can potentially allow for interference between devices. | accessdata.fda.gov |
| November 5, 2012 | 64028 | Class II | Terminated | Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement. | Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed. | accessdata.fda.gov |
| June 15, 2012 | 62566 | Class II | Terminated | Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty | Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration th | accessdata.fda.gov |
| January 24, 2012 | 62140 | Class II | Terminated | REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip s | Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition. | accessdata.fda.gov |
| October 17, 2011 | 62134 | Class II | Terminated | OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are | Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray. | accessdata.fda.gov |
| September 23, 2011 | 61969 | Class II | Terminated | Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive | Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray, Size 2F/1T. Both trays have the potential to be mislabeled. | accessdata.fda.gov |
| August 19, 2011 | 61984 | Class II | Terminated | OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm | Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification. | accessdata.fda.gov |
| March 6, 2009 | 71528 | Class II | Terminated | Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments. | Incorrect thread form on the screw. | accessdata.fda.gov |
| November 1, 2007 | 45859 | Not yet classified | Terminated | Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653 | Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 - 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads, 28mm | accessdata.fda.gov |
| December 7, 2006 | 37005 | Not yet classified | Terminated | Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13 | The outside profile on this manufactured lot of devices is oversized and does not meet specifications. | accessdata.fda.gov |
| August 31, 2006 | 36311 | Not yet classified | Terminated | Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02 | Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert. | accessdata.fda.gov |
| July 21, 2006 | 37788 | Not yet classified | Terminated | AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44. | The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device. | accessdata.fda.gov |
| December 19, 2005 | 34294 | Not yet classified | Terminated | Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY***EXACTECH Gainesvi | An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place. | accessdata.fda.gov |
| June 2, 2005 | 32568 | Not yet classified | Terminated | The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CEMENTED USE ONLY***''. | Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information. | accessdata.fda.gov |
| November 11, 2004 | 30540 | Not yet classified | Terminated | Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. | Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information. | accessdata.fda.gov |
| August 1, 2003 | 26919 | Not yet classified | Terminated | Exactech Tibial Augmentation Block Trial Size 0, Exactech Tibial Tray Trial size 1 Delta and Exactech Trapezoid Tray Trial size 1 Delta. | Misalignment of the fixation holes between the tibial augment block trials and the corresponding tibial tray trials and trapezoid tray trials. The misalignment of the pin fixation holes only creates an issue when augmentation is used. | accessdata.fda.gov |
| July 30, 2003 | 26990 | Not yet classified | Terminated | Exactech Tibial Offset Bushing (sizes 1, 2, 3, 4, & 5) Catalog Numbers 209-04-71, 209-04-72, 209-04-73, 209-04-74, and 209-04-75. | The alpha and beta markings on the offset tibial bushings are in a location that would lead to the improper selection of an offset tibial tray. | accessdata.fda.gov |
| June 17, 2003 | 26818 | Not yet classified | Terminated | Product is packed in plastic Tyvek packaging and is labeled as sterile as follows: ACUDRIVER FLEXIBLE OSTEOTOME FLAT NARROW REF: 400-40-14 | Instrument is excessively flexible making it unusable by the surgeon. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- All makers of Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- All makers of Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- All makers of Screw, Fixation, Bone
- All makers of Guide, Surgical, Instrument
Updated April 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.