Data / Medical devices / United States / Biomet Microfixation
Biomet Microfixation: FDA-registered device maker in Jacksonville, FL, United States, 75 510(k) clearances and 1 PMA approval
Biomet Microfixation is registered with the FDA (registration 1032347) in Jacksonville, FL, United States. It lists 150 device types. The FDA files 75 510(k) clearances and 1 PMA approval under its listings, the newest dated June 2, 2026. 36 recall events name it as the recalling firm. Registered through 2026. 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
- 1032347
- Address
- 1520 Tradeport Dr, Jacksonville, FL, United States, 32218
- Owner or operator
- BIOMET MICROFIXATION (1032347)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 14, 1992
- Registered through
- 2026
- Brand names listed
- 1.5mm System, 1mm System, 2.1 x 255mm Drill, 22mm Stop, 2.3mm System, 2.4mm Trocar, 2.7mm Trocar, 2mm System, 2mm Trocar 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 2, 2026 | K261002 | Pectus Blu System | HRS | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| September 19, 2024 | K241709 | Pectus Blu Support Bar System | HRS | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| August 19, 2024 | K241282 | RibFix Titan Fixation System | HRS | Substantially Equivalent | Riverpoint Medical | accessdata.fda.gov |
| November 15, 2022 | K223199 | 2.1 x 255mm Drill, 22mm Stop | HBE | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| August 23, 2022 | K213072 | 2.1 x 255mm Drill, 22mm Stop | HBE | Substantially Equivalent | Biomet Micofixation | accessdata.fda.gov |
| May 17, 2022 | K212782 | SternaLock Sternal Closure System | HRS | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| April 22, 2022 | K212608 | RibFix Blu Thoracic Fixation System | HRS | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| January 7, 2022 | K212841 | Pectus Blu Support Bar System | HRS | Substantially Equivalent | Biomet Micofixation | accessdata.fda.gov |
| August 5, 2021 | K202969 | Biomet Microfixation OmniMax MMF System | JEY | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| April 30, 2021 | K210290 | JACE Medical Thoracic Plating System | HRS | Substantially Equivalent | Jace Medical, LLC | accessdata.fda.gov |
| January 28, 2021 | K203474 | Biomet Microfixation RibFix Advantage System | HRS | Substantially Equivalent | Biomet Micofixation | accessdata.fda.gov |
| June 5, 2019 | K190576 | WalterLorenz Surgical Assist Arm Scope Holder | OCV | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| February 14, 2019 | K183317 | AdvantageRib System | HRS | Substantially Equivalent | Sig Medical Corporation | accessdata.fda.gov |
| December 9, 2016 | K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | HRS | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| November 23, 2016 | K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System | HRS | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| August 2, 2016 | K161896 | Biomet Microfixation Sternal Closure System | HRS | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| March 24, 2016 | K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | HRS | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| December 10, 2015 | K152326 | Biomet Microfixation OmniMax MMF System | JEY | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| November 3, 2015 | K151019 | SternaLock® 360 Sternal Closure System | HRS | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| May 26, 2015 | K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | HWC | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| April 1, 2015 | K143336 | Biomet Microfixation OmniMax MMF System | JEY | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| February 25, 2015 | K142823 | Biomet Microfixation Thoracic Fixation System | HRS | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| October 31, 2014 | K142484 | Sternal Closure System | HRS | Substantially Equivalent | Jace Medical, LLC | accessdata.fda.gov |
| August 7, 2014 | K141241 | MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEM | HRS | Substantially Equivalent | Synthes (USA) Products, LLC | accessdata.fda.gov |
| July 31, 2014 | K140603 | ONEPASS ENDOSCOPIC VESSEL HARVESTING SYSYETM | GEI | Substantially Equivalent | Saphena Medical, Inc. | accessdata.fda.gov |
| October 2, 2013 | K132600 | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | JEY | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| August 8, 2013 | K131674 | PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | JEY | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| October 12, 2012 | K121624 | BIOMET MICROFIXATION NEURO PLATING SYSTEM | GWO | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| September 21, 2012 | K121589 | BIOMET MICROFIXATION FACIAL PLATING SYSTEM | JEY | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| September 19, 2012 | K121302 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM | HRS | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| June 29, 2012 | K113512 | BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM | JEY | Substantially Equivalent | Biomet Microfixation | accessdata.fda.gov |
| May 4, 2012 | K112671 | STERILCONTAINER SYSTEM | KCT | Substantially Equivalent | Aesculap, Ltd. | accessdata.fda.gov |
| November 29, 2011 | K111908 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM | HWC | Substantially Equivalent | Biomet Microfixation, Inc. | accessdata.fda.gov |
| May 18, 2011 | K110574 | BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM | HRS | Substantially Equivalent | Biomet Microfixation, Inc. | accessdata.fda.gov |
| June 21, 2010 | K101080 | NON STICK BIPOLAR FORCEPS MODEL 07/XXX, BIPOLAR FORCEPS MODEL 08/XXX, MONOPOLAR FORCEPS MODEL 09/XXX | GEI | Substantially Equivalent | Egon Faulhaber Surgical Instruments Pinzetten | accessdata.fda.gov |
| July 22, 2009 | K091058 | ADKINS STRUT | HRS | Substantially Equivalent | Biomet Microfixation, Inc. | accessdata.fda.gov |
| April 2, 2009 | K082793 | INTERGRO DBM | MQV | Substantially Equivalent | Biomet Spine | accessdata.fda.gov |
| September 9, 2008 | K082293 | SURGVIEW INTEGRATED VISUALIZATION SYSTEM | HRX | Substantially Equivalent | Biovision Technologies, LLC | accessdata.fda.gov |
| May 9, 2008 | K081067 | FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) | JEY | Substantially Equivalent | Biomet Microfixation, Inc. | accessdata.fda.gov |
| February 9, 2007 | K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | OAT | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| January 12, 2007 | K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | JEY | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| December 18, 2006 | K063506 | LORENZ STERNAL CLOSURE SYSTEM | HRS | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| December 4, 2006 | K062842 | TWIST DRILL | HBE | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| November 17, 2006 | K062510 | AESCULAP STERILCONTAINER SYSTEM | FRG | Substantially Equivalent | Aesculap | accessdata.fda.gov |
| June 6, 2006 | K061384 | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM | HRS | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| May 17, 2005 | K050322 | MICROTEK EQUIPMENT DRAPES | KKX | Substantially Equivalent | Microtek Medical, Inc. | accessdata.fda.gov |
| November 8, 2004 | K042516 | OTOMIMIX | NEA | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| May 5, 2004 | K040983 | LORENZ SELF-DRILLING IMF SCREW | DZE | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| December 15, 2003 | K033740 | LORENZ STERNAL CLOSURE SYSTEM | HWC | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| June 26, 2003 | K031751 | RAPIDFIRE SELF DRILLING SCREWS | HWC | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| May 21, 2003 | K031034 | SPIN DOWN RAPIDFLAP | GXN | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| December 4, 2002 | K023718 | QUICKSET MIMIX BONE VOID FILLER | GXP | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| February 28, 2002 | K013954 | LORENZ SELF DRILLING SCREWS | HWC | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| February 22, 2002 | K020407 | LORENZ BLUE DEVICE | MQN | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| August 6, 2001 | K002790 | ADD-ON CONDYLE | NEI | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| July 16, 2001 | K011076 | LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW | HRS | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| May 3, 2000 | K001238 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM | JEY | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| November 19, 1999 | K992952 | LORENZ DISTRACTION SYSTEM | MQN | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| November 18, 1999 | K990290 | CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER | GXP | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| November 8, 1999 | K992961 | LORENZ SMALL FRAGMENT SYSTEM | HRS | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| May 13, 1999 | K983728 | LORENZ IMF SCREW | DZL | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| July 13, 1998 | K981789 | LORENZ PECTUS SUPPORT BAR STABILIZER | HRS | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| May 11, 1998 | K980512 | LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW | JEY | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| February 23, 1998 | K973080 | SURGICAL VASCULAR CLAMP | DXC | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| August 18, 1997 | K972322 | LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES | JEY | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| August 11, 1997 | K972420 | LORENZ PECTUS SUPPORT BAR | HRS | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| July 25, 1997 | K972074 | SUCTION INSTRUMENTATION | GCX | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| September 28, 1995 | K953385 | LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM | JEY | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| May 2, 1994 | K941245 | POLY-MEDICS HEAT PACK | IMD | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| September 2, 1993 | K924935 | HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT | KKY | Substantially Equivalent | Polyclinic Medical Center | accessdata.fda.gov |
| December 23, 1992 | K922741 | LORENZ 1.0 MM SYSTEM | JEY | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| February 20, 1991 | K910038 | LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM | JEY | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| February 22, 1990 | K896667 | LORENZ STENT | FWN | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| January 21, 1986 | K854886 | WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS | JEY | Substantially Equivalent | Walter Lorenz Surgical, Inc. | accessdata.fda.gov |
| May 18, 1983 | K831005 | WIRE & STEINMAN PINS | HTY | Substantially Equivalent | Kirschner Medical Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 21, 2005 | P020016 | WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | LZD | 11 | July 27, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 11, 2017 | 77022 | Class II | Terminated | Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 | Part of the number on the tray lid differ from the part number on the base. | accessdata.fda.gov |
| June 13, 2016 | 74798 | Class II | Terminated | Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting fro | Potential sterility deficiency. | accessdata.fda.gov |
| August 6, 2015 | 72366 | Class II | Terminated | Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage. | The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force. | accessdata.fda.gov |
| October 17, 2014 | 69644 | Class II | Terminated | Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand | Laser etching on the parts is wider and deeper than the conditions previously validated. | accessdata.fda.gov |
| September 20, 2013 | 67547 | Class II | Terminated | Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally reconstruct a diseased and/o | Product mix occurred prior to final package and labeling process. | accessdata.fda.gov |
| November 23, 2011 | 60682 | Not yet classified | Terminated | The SternaLock Blu Implant Tray includes plates, screws, screw measuring device, and blades. The SternaLock Blu Implant Tray would have been found within the following outer containers: Silver Instrument Tray, with a Whi | Biomet Microfixation, Inc., Jacksonville, FL recalled their SternaLock Blu Implant Tray on 11/23/11, model numbers 73-1300 through 73-1302 due to the possibility of an inaccurate reading on the Screw Measuring Area. If used incorrectly, the screw measuring area inside the SternaLock Blu Implant Tray, could lead to the improper selection of a screw 2mm longer | accessdata.fda.gov |
| November 15, 2011 | 61271 | Not yet classified | Terminated | The LactoSorb Heat/Contouring Pen is a disposable alkaline-battery powered device. Product is labeled in part: "***REF LOT***LACTOSORB* SYSTEM HEAT/CONTOURING PEN AND TIPS***QTY 00001***STERILE R STERILE EO***PVC, BRASS* | On 11/15/2011 Biomet Microfixation, Jacksonville, FL initiated a recall of their Acticort Heat/Contouring Pen, Model #, Lot #861200. Product is incorrectly labeled | accessdata.fda.gov |
| August 18, 2011 | 59943 | Not yet classified | Terminated | Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850***DISTRIBUTED BY: BIOMET MICROFIXATION 1520 | On 09/18/2011, Biomet Microfixation, Jacksonville, FL, recalled their SP-2411, Rubber Band, Lot 307850 because it was labeled and sold as "LATEX FREE" although it contains "LATEX". The firm's HHE identified this as a potential high health risk to the patients or end users with latex allergies. | accessdata.fda.gov |
| July 8, 2011 | 60421 | Not yet classified | Terminated | Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT*** MADE IN THE PHILIPPINES*** BIOMET MICROFIXATION 1520 TRADEPORT DRIVE J | Biomet Microfixation, Inc., Jacksonville, FL, recalled their IQ Intelligent Device, 72-1000 due to failure of the front bit sensor to detect the correct bit that is installed. When a screw is inserted with the device in drill mode, it is possible for the screw or bone to strip. | accessdata.fda.gov |
| November 8, 2010 | 59181 | Not yet classified | Terminated | Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER | On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5 | accessdata.fda.gov |
| October 8, 2010 | 58980 | Not yet classified | Terminated | "***REF: 922070 TMJ SYSTEM ARTHROSIMPLICITY KIT***STERILE PRODUCT***STERILE EO***DISTRIBUTED BY BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" THIS KIT WAS DISCONTINU | Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ System ArthroSimplicity Kit REF 922070 & 24-4050; TMJ System InnerVue Scope Procedure Kit REF 922090. The OnPoint Scope Kits and ArthroSimplicity Kits contain Chloraprep Swabsticks that do not contain any warnings regarding the use of the product on ey | accessdata.fda.gov |
| August 31, 2010 | 56802 | Not yet classified | Terminated | 2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG. (2.) QTY 00001, CE 0086, *** NON-STERILE PRODUCT***, 1.0 | Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate). | accessdata.fda.gov |
| July 28, 2010 | 58199 | Not yet classified | Terminated | BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBLE Y-SHAPE, REGULAR 0.6 MM TITANIUM***NON-ST | Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the package contains a 01-7112-K (1.5.6 Hold Long Double Y). | accessdata.fda.gov |
| June 25, 2010 | 59100 | Not yet classified | Terminated | Labeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 33218 USA***www.biometfixation.com***2.0 MM X 7.0 MM TITANIUM***#01-6577***LOT XXXXXX***QTY 00001***X-DRIVE FOSSA | Biomet Microfixation, Jacksonville, FL is recalling part number 01-6577, 2.0x7 mm Fossa X-drive screws, 5 pack, lot # 233270. This product is being recalled due to the possibility that the pack may have contained another part, 01-6581 2.0x11 mm Fossa x-drive screws, 5 pack. | accessdata.fda.gov |
| June 25, 2010 | 56133 | Not yet classified | Terminated | BIOMET MICROFIXATION REF: 02-0461 REES INSULATED FORCEPS, 21CM, (8.25") (L), STAINLESS STEEL, NYLON, ***NON-STERILE PRODUCT***. The Rees Insulated Forceps are used during surgery to grasp, dissect and coagulate selected | The forceps insulation may have cracks or breaks in the insulation that may cause burns to patients when used. | accessdata.fda.gov |
| May 17, 2010 | 59002 | Not yet classified | Terminated | "***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159") (WXL)***TITANIUM***NON-STERILE PRODUCT***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA*** www.biometmicrofix | On May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, Model #: 91-6704, Lot#: 173770. The product is labeled incorrectly. Some packages of 91-6704 lot 173770 are labeled as cross drive screws, but contain center drive screws. All affected customers were notified of the recall on May 17 | accessdata.fda.gov |
| April 26, 2010 | 61207 | Not yet classified | Terminated | Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM, BIOMET MICROFIXATION | On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly. | accessdata.fda.gov |
| April 7, 2010 | 60910 | Not yet classified | Terminated | The 45mm Left Standard Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint. The component is labeled | Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part # 24-6646, 45mm Left Standard Offset Mandible due to a lot of 24-6246 being etched & labeled as 24-6646 and the reverse, a lot of 24-6646 being etched and labeled as 24-6546. | accessdata.fda.gov |
| March 17, 2010 | 54370 | Not yet classified | Terminated | BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK. BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, WWW. | Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws. | accessdata.fda.gov |
| March 15, 2010 | 58920 | Not yet classified | Terminated | "***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile Product***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" Blade | Biomet Microfixation, Jacksonville, FL is recalling Center Drive Blade, 2.0, Model Number 01-9047, Lot # 064980. Product is non-conforming (blades do not retain screws). | accessdata.fda.gov |
| January 15, 2010 | 54375 | Not yet classified | Terminated | BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT. Part Number SP-1918 BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA. | The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone consolidation may occur and a second surgery may be necessary. | accessdata.fda.gov |
| November 6, 2009 | 53943 | Not yet classified | Terminated | Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA. A single use twist drill intended f | The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU). | accessdata.fda.gov |
| October 6, 2009 | 54372 | Not yet classified | Terminated | BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSON | Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw. | accessdata.fda.gov |
| October 5, 2009 | 54366 | Not yet classified | Terminated | BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***. Bone screws used along with implantable bone plates for oral, cranio- | Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw. | accessdata.fda.gov |
| September 15, 2009 | 53845 | Not yet classified | Terminated | LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF:, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. Lacto Sorb Self Drilling Taps are | Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers Lot # 064350 and Lot # 885580. The two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. Depending on the tap (1.5mm VS 2.0mm) you may drill too shallow or too deep. | accessdata.fda.gov |
| March 20, 2009 | 51668 | Not yet classified | Terminated | Lactosorb Pectus Stabilizer, model number: 01-3805. Distributed and Manufactured by : Biomet Microfixation, Jacksonville, FL. LactoSorb Pectus Stabilizer is a surgical implant intended to aid in the treatment of Pectus E | This recall is based on the occurrence of known adverse effects identified in the device instructions for use. Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing. Implantation of foreign materials can result in an inflammatory response or allergic reaction. | accessdata.fda.gov |
| February 19, 2009 | 52639 | Not yet classified | Terminated | Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows: REF: 01-0264, QTY,UOM 00001, BYRD SCREW, 2 OX6MM SELF-DRILLING, 12CM, (4-3/4) (L), STAINLESS STEEL, LOT 999999, (01) 00841036007157 | Byrd Screw, Self Drilling, may break during usage. BIOMET has determined that the parts were not correctly processed by the vendor, i.e. that the parts were not hardened in the final processing and that lead to weaker than acceptable material. | accessdata.fda.gov |
| February 16, 2009 | 52672 | Not yet classified | Terminated | BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP STAINLESS STEEL, NON-STERILE, BIOMET MICROFIXATION, INC. 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA. | Biomet Microfixation is recalling the 46-1004, Trauma One Drill, 18.x115 mm, 26 mm Stop Lot Numbers 619450 and JC1002. The drills may be color-banded blue instead of brown. The color is a visual aid in determining what system the drill goes with. The blue indicates the drill is for the 2.0mm system. The brown indicates the drill is to be used for our 2.3mm s | accessdata.fda.gov |
| January 9, 2009 | 53584 | Not yet classified | Terminated | BD Recalled component is labeled: BD 60ml Syringe Luer-Lok Tip, REF 309653 STERILE. BD Franklin Lakes, NJ 07417 USA Made in USA, www.bd.com. Lots 7298534 Exp 2012-10 and 7334153 Exp 2012-11. Component is found in: TMJ SY | Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and Arthrosimplicity TMJ Arthocentesis Kit (Part Numbers 922070, 922090, 922075). These two kits contain a BD sterile disposable 60 ml Luer-Lok syringe, Part number 309653 which is under recall by Becton Dickinson (Recall Number Z-2347-2008). Becton Dickinson has de | accessdata.fda.gov |
| October 24, 2008 | 50149 | Not yet classified | Terminated | Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures to retract tissue. | Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08. | accessdata.fda.gov |
| August 6, 2008 | 50516 | Not yet classified | Terminated | REF: Lactosorb System, Lacto Endobrow Lift Complete, 10X13CM. (3.75X5.25") (WXL), Polypropylene, Radel. Non Sterile Product. W.LORENZ SURGICAL, Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Reply to Post Office Box 1 | Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label. | accessdata.fda.gov |
| July 11, 2008 | 50113 | Not yet classified | Terminated | HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures. | The packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot 493200 actually contained the 99-6577, 2.0X7MM FOSSA X-DRIVE SCREW. | accessdata.fda.gov |
| May 21, 2008 | 50737 | Not yet classified | Terminated | Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. Walter Lorenz Surgical, Inc., Subsidiary of Biomet Microfixation, Inc. NOTE: None distributed do | The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997. | accessdata.fda.gov |
| April 16, 2008 | 48458 | Not yet classified | Terminated | Stella Interdental Osteotome, 4mm, 6mm and 8mm. Model numbers 01-0575, 01-0576 and 01-0578. Product is intended to be used during the interdental osteotomy (bone cutting). | The working tips of the Stella Osteotomes are thicker than specification. | accessdata.fda.gov |
| March 19, 2008 | 48461 | Not yet classified | Terminated | Lactosorb Trauma Plating System, part numbers:,,,,,, and CP-1323. The system is used in trauma and reconstructive surgical procedures in the mid face and craniofacial skeleton. Used to support non-load bearing tissues of | The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy bioburden would increase the potential for bone infection (osteomyelitis). | accessdata.fda.gov |
| February 17, 2006 | 34843 | Not yet classified | Terminated | Product is 40mm Flexible Tube. ***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DRIVE, REPLY | Lorenz Engineer discovered flex tube could break if bent too much. | accessdata.fda.gov |
Compare with other makers
- All makers of Screw, Fixation, Bone
- All makers of Plate, Bone
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Headlamp, Operating, Battery-Operated
- All makers of Motor, Surgical Instrument, Ac-Powered
- All makers of Pliers, Surgical
Updated July 27, 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.