Data / Medical devices / United States / Wright Medical Technology, Inc.
Wright Medical Technology, Inc.: FDA-registered device maker in Arlington, TN, United States, 187 510(k) clearances
Wright Medical Technology, Inc. is registered with the FDA (registration 1043534) in Arlington, TN, United States. It lists 94 device types. The FDA files 187 510(k) clearances under its listings, the newest dated June 16, 2026. 29 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1043534
- Address
- 11576 Memphis-Arlington Rd, Arlington, TN, United States, 38002
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- January 10, 1978
- Registered through
- 2027
- Brand names listed
- 10.5MM FLEXIBLE REAMER, 10MM FLEXIBLE REAMER, 10mm SUBFIX TRIAL, 11.5MM FLEXIBLE REAMER, 11.5mm SUBFIX TRIAL, 11MM FLEXIBLE REAMER, 12MM FLEXIBLE REAMER, 135 mm Reusable Slat, SE Retr, 10 Pack 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 187.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 16, 2026 | K253159 | Prophecy Incompass Surgical Planning System | HSN | Substantially Equivalent | Wright Medical Technology, Inc. (Stryker) | accessdata.fda.gov |
| October 29, 2025 | K251643 | Synchfix EVT | HTN | Substantially Equivalent | Wright Medical Technology, Inc. (Stryker Corporation) | accessdata.fda.gov |
| September 30, 2025 | K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom) | MQV | Substantially Equivalent | Wright Medical Technology, Inc. (Stryker Corporation) | accessdata.fda.gov |
| June 20, 2025 | K250037 | Incompass Total Ankle System | HSN | Substantially Equivalent | Wright Medical Technology, Inc. (Stryker) | accessdata.fda.gov |
| November 1, 2024 | K241999 | Prophecy Surgical Planning System | HSN | Substantially Equivalent | Wright Medical Technology, Inc. (Stryker) | accessdata.fda.gov |
| February 17, 2023 | K221645 | PROstep(TM) MIS 5mm Chamfer Screw System | HWC | Substantially Equivalent | Wright Medical Technology | accessdata.fda.gov |
| January 27, 2023 | K222835 | Prophecy Preoperative Navigation Alignment System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 5, 2022 | K213342 | PRO-DENSE LoVisc Bone Graft Substitute | MQV | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| November 16, 2021 | K212996 | Sterile PHALINX Hammertoe System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 11, 2021 | K203228 | DART-FIRE EDGE Cannulated Screw System | HWC | Substantially Equivalent | Wright Medical | accessdata.fda.gov |
| May 7, 2021 | K203832 | FuseForce Flex Dynamic Compression System | JDR | Substantially Equivalent | Wright Medical | accessdata.fda.gov |
| March 10, 2021 | K202815 | PROPHECY Preoperative Navigation Alignment System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| June 8, 2020 | K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 22, 2019 | K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 13, 2019 | K190970 | PROSTEP TBI (Tailors Bunion Implant) System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| June 6, 2019 | K183620 | PROSTEP TBC Implant System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 28, 2019 | K190482 | IGNITE Bone Void Filler | MQV | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 14, 2019 | K190670 | ORTHOLOC 2 Lapidus with Rotation System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 14, 2019 | K190283 | PROSTIM Injectable Inductive Graft | MQV | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 13, 2019 | K183026 | Wright Jones Fracture System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| September 12, 2018 | K181255 | PRODENSE Bone Graft Substitute | MQV | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 9, 2018 | K181557 | INFINITY Total Ankle System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 11, 2018 | K180024 | SALVATION Midfoot Nail | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| June 6, 2018 | K180832 | SALVATION External Fixation System | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 26, 2018 | K172633 | INFINITY Total Ankle System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| September 21, 2017 | K171852 | DARCO Locking Bone Plate System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| September 11, 2017 | K171067 | INVISION Total Ankle Revision System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 22, 2017 | K170642 | GRAVITY Soft Tissue Repair System | GAT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 16, 2017 | K170968 | PROPHECY INVISION Pre-operative Navigation System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| June 30, 2017 | K170249 | GRAVITY Syndesmosis LP | HTN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 26, 2017 | K170889 | HV Screw System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 24, 2017 | K163650 | ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 13, 2017 | K162353 | MICATM Screw System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 13, 2017 | K163039 | ORTHOLOC® 3Di Small Bones Plating | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 6, 2017 | K162033 | SALVATION External Fixation System | KTT | Substantially Equivalent | Wright Medical | accessdata.fda.gov |
| February 22, 2017 | K162795 | PROPHECY INVISION Preoperative Navigation Alignment System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 26, 2017 | K163044 | ORTHOLOC® 3Di Ankle Fracture Plating System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 17, 2016 | K152062 | BIOFOAM Bone Wedge | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 6, 2016 | K153008 | INVISION Total Ankle Revision System | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 13, 2016 | K153635 | SALVATION(R) External Fixation System | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 11, 2015 | K152974 | ORTHOLOC® 3Di Foot Plating Reconstruction System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| September 4, 2015 | K151838 | PRO-TOE Hammertoe Fixation System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 21, 2015 | K152045 | SALVATION® External Fixation System | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 20, 2015 | K142724 | BIOFOAM Bone Wedge | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 8, 2015 | K150213 | Subtalar Spacer System (STS) | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 29, 2015 | K150520 | DARCO Locking Bone Plate System | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 29, 2015 | K150252 | PHALINX Hammertoe System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 25, 2015 | K142117 | INVISION TOTAL ANKLE REVISION SYSTEM | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 5, 2015 | K141740 | INFINITY (TM) TOTAL ANKLE SYSTEM; INBONE TOTAL ANKLE SYSTEM | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 4, 2015 | K150004 | SALVATION External Fixation System | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 10, 2015 | K150073 | MICRONAIL Distal Radius System | HSB | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 23, 2015 | K143460 | Cannulated Screw System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 8, 2015 | K143220 | SIDEKICK EZ FRAME External Fixation System | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 5, 2014 | K143025 | TOTAL COMPRESSION PLATING SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| November 20, 2014 | K142585 | PhaLinx Hammertoe System | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 24, 2014 | K141714 | PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM | HTY | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 22, 2014 | K142602 | VALOR Hindfoot Fusion Nail System | HSB | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 21, 2014 | K142121 | VALOR HINDFOOT FUSION NAIL SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 30, 2014 | K141011 | G-FORCE GEN 2 SUTURE ANCHOR SYSTEM | MBI | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 9, 2014 | K141417 | CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 9, 2014 | K140531 | BIOFOAM BONE WEDGE | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 22, 2014 | K140792 | SALVATION 3DI PLATING SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 15, 2014 | K140952 | CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 15, 2014 | K140741 | SALVATION BEAMS AND BOLTS SYSTEM | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 14, 2014 | K140408 | SALVATION OSTEOPENIC SCREW | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 25, 2014 | K140749 | INFINITY TOTAL ANKLE SYSTEM | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 24, 2014 | K132656 | PRODENSE BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 7, 2014 | K140148 | PRO-TOE HAMMERTOE FIXATION SYSTEM | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 7, 2014 | K133713 | CHARLOTTE (TM) SNAP-OFF SCREW | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 28, 2014 | K133715 | CHARLOTTE CLAW PLATE SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| February 20, 2014 | K133585 | INBONE TOTAL ANKLE | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 13, 2013 | K132594 | CROSSCHECK PLATING SYSTEM | HRS | Substantially Equivalent | Solana Surgical, LLC | accessdata.fda.gov |
| October 22, 2013 | K131187 | LESSER METATARSAL HEAD IMPLANT SYSTEM | KWD | Substantially Equivalent | Solana Surgical, LLC | accessdata.fda.gov |
| July 10, 2013 | K124045 | FUSEFORCE IMPLANT SYSTEM | JDR | Substantially Equivalent | Solana Surgical, LLC | accessdata.fda.gov |
| July 5, 2013 | K131283 | PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 21, 2013 | K131093 | ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 5, 2013 | K130044 | SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM | KTT | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 1, 2013 | K123954 | INFINITY TOTAL ANKLE SYSTEM | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 4, 2013 | K123059 | INBONE ( I AND II) TOTAL ANKLE SYSTEMS | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 12, 2012 | K121651 | ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 1, 2012 | K121425 | ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 25, 2012 | K113006 | I-FUSE HAMMER TOE SYSTEMS | HWC | Substantially Equivalent | Orthopro, LLC | accessdata.fda.gov |
| May 3, 2012 | K120359 | ORTHOLOC 3DI HALLUX SYSTEM | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 24, 2012 | K120645 | PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| April 2, 2012 | K120802 | ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 31, 2012 | K113014 | CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 16, 2011 | K110360 | PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 12, 2011 | K113339 | ORTHOLOC 3DSI LOCKING SCREWS | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| October 7, 2011 | K112772 | ORTHOLOC(TM) BONE SCREWS | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 19, 2011 | K111432 | EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| May 4, 2011 | K102324 | ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| March 23, 2011 | K110552 | VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW | HSB | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| January 14, 2011 | K102601 | ORTHOFLEX ROD | KWH | Substantially Equivalent | Ortho-Pro, LLC | accessdata.fda.gov |
| December 14, 2010 | K103374 | INBONE TOTAL ANKLE SYSTEM MODEL 200347902 | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| December 2, 2010 | K102352 | EVOLVE EPS ORTHOLOC | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| November 23, 2010 | K102429 | ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW | HRS | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| August 26, 2010 | K100886 | INBONE II TOTAL ANKLE REPLACEMENT | HSN | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| July 23, 2010 | K101165 | PRO-TOE VO HAMMERTOW IMPLANT SYSTEM | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| June 24, 2010 | K100359 | DARCO HEADED CANNULATED SCREW | HWC | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
| June 11, 2010 | K100630 | G-FORCE PEEK SUTURE ANCHOR SYSTEM | MBI | Substantially Equivalent | Wrightmedicaltechnologyinc | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 3, 2021 | 89089 | Class II | Ongoing | Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: 4, 30mm, REF 40240430. | The incorrect product is contained in the packaging. | accessdata.fda.gov |
| November 4, 2021 | 89007 | Class II | Terminated | INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS | The package contents and package labeling do not match. | accessdata.fda.gov |
| August 26, 2020 | 86278 | Class II | Terminated | EVOLVE STEM 8.5MM Model # 496S085 | Lack of sterility assurance | accessdata.fda.gov |
| April 9, 2020 | 85439 | Class II | Terminated | WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movemen | One lot of INBONE Tibial Trays is missing the plasma coating. | accessdata.fda.gov |
| March 14, 2018 | 79581 | Class II | Terminated | WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020 | Tow lot of VALOR(TM) Nail could potentially be missing the assembled compression screw. | accessdata.fda.gov |
| November 8, 2016 | 84180 | Class II | Terminated | SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104 | The firm discovered a lack of adequate documentation confirming sterility on certain products. | accessdata.fda.gov |
| September 5, 2012 | 63338 | Class II | Terminated | Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, | There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. | accessdata.fda.gov |
| April 5, 2012 | 61602 | Not yet classified | Terminated | VALOR(R), TARGETING GUIDE, REF 4150011000, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The VALOR" Ankle Fusion Nail System is intended to facilitate tibiotalocalcaneal arthrodesis to treat s | The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage. | accessdata.fda.gov |
| January 3, 2012 | 60947 | Not yet classified | Terminated | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 46mm GROUP B, REF DSBFGB46, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell. | The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery. | accessdata.fda.gov |
| September 20, 2011 | 59998 | Not yet classified | Terminated | ANCHORLOK(R) LEADING EDGE(R) SOFT TISSUE ANCHOR SYSTEM, 1.9mm, 2.0 SUTURE, REF 5100-002, 1 each, STERILE R, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Product Usage: The instrument is used a | The product is labeled with an expiration date without adequate justification. | accessdata.fda.gov |
| April 20, 2011 | 58717 | Not yet classified | Terminated | ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005950, LOT 088605355, IMPLANT MATERIAL: Wright Medical Technology, Inc, 5677 Airline Road, Arlington, TN 38002 The ENDO-FUSE(R) I | Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery. | accessdata.fda.gov |
| January 11, 2011 | 57854 | Not yet classified | Terminated | TI ANCHOR 1.9MM W / 2-0 SUTURE, G-FORCE SUTURE ANCHOR, Tissue Anchor, REF 86TA-1920, Rx ONLY, Sterile EO, Wright, Arlington, TN USA Used in the repair of tendons and ligaments | Driver may break during use. | accessdata.fda.gov |
| August 26, 2010 | 56667 | Not yet classified | Terminated | DRIVER STAR #8 CANNULATED DART-FIRE (TM), COMPRESSION SCREW, SIZE: #8, REF: DSDS-0008, 1 EACH, Rx ONLY, NON-STERILE, EC REP Wright Medical EMEA, Krijgsman 11, 1186 DM Amstelveen, The Netherlands, Wright Medical Technolog | After autoclaving, the epoxy identifier (colored) band bled and there is concern that it may flake. | accessdata.fda.gov |
| June 7, 2010 | 56131 | Not yet classified | Terminated | DYNASTY A-CLASS POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o, LINER STD, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Product is used in total hip arthroplast | The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization method. | accessdata.fda.gov |
| June 7, 2010 | 56091 | Not yet classified | Terminated | CLAW HEX SCREW CHARLOTTE " F&A SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw... IMPLANT MATERIAL: Stainless Steel Ref: 4013-3520... Size 3.5MM, Length 20 MM, Use with Clava 3.5MM - Non-Sterile. Implantation: used in Food | One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws. | accessdata.fda.gov |
| April 8, 2010 | 55637 | Not yet classified | Terminated | RAYHACK DRILL GUIDE ANGLED, REF 4010-0206, 1 EACH, Rx ONLY, NON-STERILE, Wright Medical EMEA Krijgsman 11, 1186 Amstelveen, The Netherlands, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002 Intended use: | Drill guides from 2 lots may not seat properly on the compression block. | accessdata.fda.gov |
| February 19, 2010 | 54677 | Not yet classified | Terminated | ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. The device is intended for use in total knee arthro | The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of the correct 5 mm length screws). | accessdata.fda.gov |
| November 24, 2009 | 55436 | Not yet classified | Terminated | ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Indicated for use in knee arthroplasty for r | The left medial pivot and right medial pivot inserts were co-mingled | accessdata.fda.gov |
| September 22, 2009 | 53538 | Not yet classified | Terminated | ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-0140, DIAMETER 11mm, LENGTH 140mm, 1 EACH, STERILE R, (FOR USE WITH CEMENT ONLY), SINGLE USE ONLY, (Ti6A14V), Wright Medical Technology, Inc., 5677 Airline Road, Arling | Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an area with less strength. For those instances where the product has been implanted, there is the potential increased risk o | accessdata.fda.gov |
| May 14, 2009 | 52217 | Not yet classified | Terminated | CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002. The CONSERV | Incorrect packaging, swapped sizes | accessdata.fda.gov |
| February 19, 2009 | 51431 | Not yet classified | Terminated | Screwdriver for 3.5mm Screws, DARCO system, instrument for use in orthopaedic implant surgery. REF: DC4261, Non-sterile, Rx only, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 | The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated. | accessdata.fda.gov |
| May 20, 2008 | 48687 | Not yet classified | Terminated | Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Orthopaedic instrument used for the preparation of the implant site | Trials are 2.5mm larger than marked. | accessdata.fda.gov |
| October 4, 2007 | 45462 | Not yet classified | Terminated | Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002 | Breakage: breaking of the connecting foot that is on the distal surface of the instrument | accessdata.fda.gov |
| March 27, 2007 | 37826 | Not yet classified | Terminated | Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only Hip implant. | The titanium plasma coating was found to have missing fragments. | accessdata.fda.gov |
| January 3, 2007 | 37250 | Not yet classified | Terminated | Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm O.D., use with 22 mm Head | Product specification failure which could result in improper locking of the cup onto the femoral head. | accessdata.fda.gov |
| January 3, 2006 | 34526 | Not yet classified | Terminated | Guardian Distal Femur Axial Pin | The product was not fully assembled prior to packaging. | accessdata.fda.gov |
| July 14, 2004 | 29664 | Not yet classified | Terminated | Guardian Distal Femur Axial Pin | Potential for self -locking axial pin to dislodge and 'back out'. | accessdata.fda.gov |
| July 2, 2004 | 29559 | Not yet classified | Terminated | Achillon minimally invasive Achilles tendon suture system | Lack of sterility assurance | accessdata.fda.gov |
| August 18, 2003 | 26948 | Not yet classified | Terminated | Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system. | Wright Medical commercially distributed Transcend alumina acetabular shell liners lacking the required process validation. | accessdata.fda.gov |
Compare with other makers
- All makers of Gauge, Depth
- All makers of Splint, Hand, And Components
- All makers of Blade, Saw, General & Plastic Surgery, Surgical
- All makers of Tape, Measuring, Rulers And Calipers
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
Updated June 16, 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.