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.

126–150 of 255

  • ModerateFDA (Devices)·Z-1648-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1664-2020·2020-04-15

    Biomet Recalls Knee Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling BIOMET StageOne Knee Femoral Cement Spacer Molds because the cleaning process may have been insufficient or inadequately monitored.

    Product
    BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1651-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet, Inc. is recalling specific lots of StageOne Select Hip Stem Cement Spacer Molds because of a potentially insufficient cleaning process or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1661-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1653-2020·2020-04-15

    Biomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns

    Biomet, Inc. is recalling 230,001 units of BIOMET StageOne Hip Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1658-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1650-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1669-2020·2020-04-15

    Biomet Recalls Knee Tibial Cement Spacer Molds Due to Cleaning Concerns

    Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds because of potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1659-2020·2020-04-15

    Biomet Shoulder Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling StageOne Shoulder Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1662-2020·2020-04-15

    Biomet Recalls Knee Spacer Molds Due to Insufficient Cleaning Process

    Biomet, Inc. is recalling 230,001 units of StageOne Knee Femoral Cement Spacer Molds due to a potentially insufficient cleaning process or inadequate process monitoring.

    Product
    BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1646-2020·2020-04-15

    Biomet Recalls Hip Stem Cement Spacer Molds Due to Cleaning Concerns

    Biomet, Inc. is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 155 MM, Silicone, Sterile, Item 431193.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1644-2020·2020-04-15

    Biomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling 230,001 units of StageOne Select Hip Stem Cement Spacer Molds due to potentially insufficient cleaning processes and inadequate monitoring.

    Product
    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1668-2020·2020-04-15

    Biomet Knee Tibial Cement Spacer Mold Recalled for Cleaning Process Concerns

    Biomet is recalling 230,001 units of StageOne Knee Tibial Cement Spacer Molds due to potentially insufficient cleaning processes or inadequate monitoring of cleaning parameters.

    Product
    BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
    Category
    Medical Device
    Distribution
    49 states
  • ModerateFDA (Devices)·Z-1615-2020·2020-04-08

    Biomet Shoulder Baseplate Recall Due to Incorrect Packaging Contents

    Biomet is recalling 21 units of Comprehensive Reverse Shoulder Glenosphere Mini Baseplates because some packages contained two baseplates and no taper adapters.

    Product
    Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency Item Number: 010000589
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1543-2020·2020-04-01

    Biomet Recalls Misidentified 9mm Shoulder Mini Humeral Stem Implants

    Biomet is recalling 14 units of 9mm Shoulder Mini Humeral Stems that were misidentified as 15mm units. The error poses a risk of improper surgical implantation.

    Product
    Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1173-2018·2018-04-04

    Biomet Recalls Orthopedic Implants Due to Screw Hole Mismatch

    Biomet is recalling 634 Zimmer Biomet Comprehensive Segmental Revision System implants because a screw hole mismatch may prevent proper assembly during surgery.

    Product
    Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2240-2016·2016-07-27

    Biomet Recalls TSP Hip Fracture Plating System Due to Screw Fracture Risk

    Biomet, Inc. is recalling 5,458 units of the TSP Hip Fracture Plating System because screws may fracture during implantation, potentially leaving a foreign body in the patient.

    Product
    TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems are indicated for use in the open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures and intertrochante
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1823-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet, Inc. is recalling specific trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1817-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Implants Due to Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Plate, fixation, bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2016·2016-06-01

    Biomet Recalls Trauma and Spinal Implants Due to Sterile Seal Defects

    Biomet is recalling various trauma, sports medicine, and spinal implants because insufficient seal strength may compromise sterility, potentially leading to infection.

    Product
    Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1819-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility.

    Product
    Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1818-2016·2016-06-01

    Biomet Recalls Arthroscopes and Implants Due to Sterile Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and arthroscopes because insufficient seal strength on sterile packaging could allow the product to become nonsterile.

    Product
    Various trauma and sports medicine instruments and implants. Arthroscope.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1828-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Implants Due to Seal Defects

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2016·2016-06-01

    Biomet Recalls Orthopedic Instruments Due to Sterile Packaging Seal Defect

    Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility.

    Product
    Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2016·2016-06-01

    Biomet Recalls Trauma and Sports Medicine Instruments Due to Seal Defects

    Biomet, Inc. is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility and lead to infection.

    Product
    Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide