The Recall Desk

Manufacturer

Biomet, Inc.

255 recalls in our database name Biomet, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
255
Critical
0
Severe
9
Most recent
2026-08-12

Of the 255 recalls from Biomet, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (4%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

76–100 of 255

  • HighFDA (Devices)·Z-0624-2021·2020-12-23

    Biomet Oxford Fixed Lateral Knee Implants Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of Oxford Fixed Lateral knee implants because a breach in the sterile seal could lead to loss of sterility.

    Product
    Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2021·2020-12-23

    Biomet Recalls Titanium IFS Devices Due to Potential Sterile Seal Breach

    Biomet, Inc. is recalling 7,428 units of Titanium IFS devices (Item 909680) because a breach in the sterile seal could lead to loss of sterility.

    Product
    Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0625-2021·2020-12-23

    Biomet Phoenix Interlocking Screws Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of Phoenix interlocking screws because a breach in the sterile seal could lead to loss of sterility.

    Product
    PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fracture fixation of small bones, small bone fragements and long bones.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0621-2021·2020-12-23

    Biomet Custom Cancellous Thread Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of Custom Cancellous Thread devices because a breach in the sterile seal could lead to loss of sterility.

    Product
    Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fract
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0631-2021·2020-12-23

    Biomet RingLoc+ Drill Bits Recalled for Potential Sterile Seal Breach

    Biomet is recalling specific lots of RingLoc+ Quick Connect Drill Bits because a breach in the sterile seal could lead to loss of sterility.

    Product
    RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2021·2020-12-23

    Biomet RapidFire Clip Recall Due to Potential Sterile Seal Breach

    Biomet is recalling specific lots of RapidFire Clips used for craniofacial bone fixation because a breach in the sterile seal could lead to loss of sterility.

    Product
    RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0627-2021·2020-12-23

    Biomet Ringloc Acetabular System Screws Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of Ringloc Acetabular System self-tapping bone screws because a breach in the sterile seal could lead to loss of sterility.

    Product
    RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Met
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0623-2021·2020-12-23

    Biomet OSS Polyethylene Tibial Bushing Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of OSS Polyethylene Tibial Bushings because a breach in the sterile seal could lead to loss of sterility.

    Product
    OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0620-2021·2020-12-23

    Biomet Shoulder System Surgical Handles Recalled for Sterile Seal Breach

    Biomet is recalling specific lots of sterile shoulder system surgical instrument handles because a breach in the packaging seal could lead to loss of sterility.

    Product
    Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2021·2020-10-21

    Biomet Recalls RingLoc Hip Cups Due to Double Sterilization

    Biomet is recalling 48 RingLoc Bi-Polar Hip System Acetabular Cups because they were gamma sterilized twice, which may compromise functionality and shelf life.

    Product
    (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, Ar
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0093-2021·2020-10-21

    Biomet Shoulder Prosthesis Baseplate Packaging Error Recall

    Biomet is recalling 3 units of Comprehensive Reverse Shoulder Glenosphere Mini Baseplates due to packaging errors where components may be missing or duplicated.

    Product
    Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0082-2021·2020-10-14

    Biomet OnPoint Scope Procedure Kit Recalled for Sterilization Defect

    Biomet is recalling OnPoint Scope Procedure Kits because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0081-2021·2020-10-14

    Biomet Regenerex Primary Taper Cap Recalled for Sterilization Defect

    Biomet is recalling Regenerex Primary Taper Caps because they were not properly aligned for gamma sterilization, potentially leaving them unsterilized.

    Product
    Biomet Regenerex Primary Taper Cap Item Number 141269
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0084-2021·2020-10-14

    Biomet ARTHROSIMPLICITY KIT EU Recalled Due to Sterilization Defect

    Biomet is recalling ARTHROSIMPLICITY KIT EU units because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0083-2021·2020-10-14

    Biomet ONPOINT SCOPE PROCEDURE KIT-EU Recalled for Sterilization Defect

    Biomet, Inc. is recalling ONPOINT SCOPE PROCEDURE KIT-EU units because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2020·2020-06-17

    Biomet Recalls Comprehensive VRS Inserter Shoulder Prosthesis Devices

    Biomet is recalling 38 Comprehensive VRS Inserter shoulder prosthesis devices because the central screw drill may seize, potentially extending surgery time.

    Product
    Comprehensive VRS Inserter, shoulder prosthesis, Item No. 110019068. UDI: (01)00880304829503 (10)814100, (01)00880304829503 (10)570640, (01)00880304829503 (10)728890, (01)00880304829503 (10)977300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2146-2020·2020-06-03

    Biomet Recalls Regenerex Knee Prostheses Due to Potential Endotoxin Levels

    Biomet is recalling 15 units of Regenerex Series-A Patella knee prostheses due to potential endotoxin levels exceeding specifications.

    Product
    Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2148-2020·2020-06-03

    Biomet Oxford Partial Knee Systems Recalled for Elevated Endotoxin Levels

    Biomet, Inc. is recalling 76 units of Oxford Partial Knee Systems due to potential endotoxin levels exceeding specification limits.

    Product
    Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D4 154339 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D7 154
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2156-2020·2020-06-03

    Biomet Recalls Custom Knee Prosthesis Due to Potential Endotoxin Levels

    Biomet, Inc. is recalling a specific custom-made knee prosthesis due to the potential presence of elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550 Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2151-2020·2020-06-03

    Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels

    Biomet, Inc. is recalling 11 units of Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specification limits.

    Product
    Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM 189700 Vanguard Knee System, CR Mono Lock
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2153-2020·2020-06-03

    Biomet Vanguard Knee System Recalled for Elevated Endotoxin Levels

    Biomet is recalling 93 Vanguard Knee System tibial bearings due to potential endotoxin levels exceeding specifications. The recall covers units distributed worldwide.

    Product
    Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee Sys
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2147-2020·2020-06-03

    Biomet Recalls Knee Prosthesis Components Due to Endotoxin Concerns

    Biomet, Inc. is recalling 12 units of the Orthopedic Salvage System Tibial Bearing because of potential elevated endotoxin levels.

    Product
    Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2154-2020·2020-06-03

    Biomet Recalls Vanguard Knee Implants Due to Endotoxin Levels

    Biomet, Inc. is recalling 91 Vanguard Knee System patella implants because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosthesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2152-2020·2020-06-03

    Biomet Recalls Vanguard Knee System Bearings Due to Endotoxin Levels

    Biomet, Inc. is recalling 107 units of Vanguard Knee System PS Mono Lock Tibial Bearings because they may contain elevated endotoxin levels that exceed specification limits.

    Product
    Knee Products: 189420 Vanguard Knee System, PS Mono Lock Tibial Bearing, 10 MM X 63 MM 189422 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 63 MM 189442 Vanguard Knee System, PS Mono Lock Tibial Bearing, 12 MM X 67 MM 189460 Vanguard Knee System, PS Mono Lock Tib
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2145-2020·2020-06-03

    Biomet Recalls RingLoc Hip System Components Due to Endotoxin Levels

    Biomet, Inc. is recalling specific RingLoc Hip System components due to potential elevated endotoxin levels that exceed specification limits.

    Product
    Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthrop
    Category
    Medical Device
    Distribution
    Distributed nationwide