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Biomet Recalls

279 recalls on record · September 26, 2012 to August 12, 2026 · Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

June 3, 2020Medical DevicesFDA
Biomet, Inc. recalls Knee Products: 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM 189720 Vanguard Knee System,
Hazard: Potential presence of elevated endotoxin levels that exceed the specification limit
June 3, 2020Medical DevicesFDA
Biomet, Inc. recalls Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial B
Hazard: Potential presence of elevated endotoxin levels that exceed the specification limit
June 3, 2020Medical DevicesFDA
Biomet, Inc. recalls Knee Products: 155308 Knees AGC Knee System PS Molded Tibial Component, 10 MM X 65 MM 155326 Knees AGC Knee System PS
Hazard: Potential presence of elevated endotoxin levels that exceed the specification limit
June 3, 2020Medical DevicesFDA
Biomet, Inc. recalls Knee Products: 154335 Oxford Partial Knee System, Fixed Lateral Tibial Construct, Left, Cemented, D3 154336 Oxford Par
Hazard: Potential presence of elevated endotoxin levels that exceed the specification limit
June 3, 2020Medical DevicesFDA
Biomet, Inc. recalls Knee Products: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard - Product Usage: Knee prosthesis
Hazard: Potential presence of elevated endotoxin levels that exceed the specification limit
June 3, 2020Medical DevicesFDA
Biomet, Inc. recalls Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product
Hazard: Potential presence of elevated endotoxin levels that exceed the specification limit
June 3, 2020Medical DevicesFDA
Biomet, Inc. recalls Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingL
Hazard: Potential presence of elevated endotoxin levels that exceed the specification limit
June 3, 2020Medical DevicesFDA
Biomet, Inc. recalls Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Hume
Hazard: Potential presence of elevated endotoxin levels that exceed the specification limit
April 29, 2020Medical DevicesFDA
Biomet, Inc. recalls Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended
Hazard: There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Knee Tibial Cement Spacer Mold, 80 MM, Silicone, Sterile, Item 433180.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Knee Tibial Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 433170.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Knee Femoral Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 432175.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Knee Femoral Cement Spacer Mold, 70 MM, Silicone, Sterile, Item 432170.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne, Shoulder Cement Spacer Mold 14 MM, 58 X 24 X 64 MM, Silicone, Sterile, Item 431414.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne, Shoulder Cement Spacer Mold 8 MM, 46 X 18 X 53 MM, Silicone, Sterile, Item 431408.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 17 X 165 MM, 64 MM, Silicone, Sterile, Item 431217.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 43 MM, Silicone, Sterile, Item 431207.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.