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.
April 15, 2020Medical DevicesFDA
Biomet, Inc. recalls BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
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, 9 X 200 MM, Silicone, Sterile, Item 431195.
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 165 MM, Silicone, Sterile, Item 431194.
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 155 MM, Silicone, Sterile, Item 431193.
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 145 MM, Silicone, Sterile, Item 431192.
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, 11 X 135 MM, Silicone, Sterile, Item 431191.
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, 9 X 125 MM, Silicone, Sterile, Item 431190.
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 with Insert, 64 MM, Silicone, Sterile, Item 431185.
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 with Insert, 60 MM, Silicone, Sterile, Item 431184.
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 with Insert, 56 MM, Silicone, Sterile, Item 431183.
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 with Insert, 52 MM, Silicone, Sterile, Item 431182.
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 with Insert, 48 MM, Silicone, Sterile, Item 431181.
Hazard: Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
April 8, 2020Medical DevicesFDA
Biomet, Inc. recalls Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate With Taper Adapter-indicated for primary, fracture, or
Hazard: Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
April 1, 2020Medical DevicesFDA
Biomet, Inc. recalls Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehe
Hazard: A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.
April 4, 2018Medical DevicesFDA
Biomet, Inc. recalls Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Di
Hazard: During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.
July 27, 2016Medical DevicesFDA
Biomet, Inc. recalls TSP Hip Fracture Plating System device, fixation, proximal femoral, implant The Biomet Hip Fracture Plating Systems ar
Hazard: The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Fastener, fixation, nondegradable, soft tissue.
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Appliance, fixation, nail/blade/plate combination, multipl
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Passer.
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Screw, fixation, bone.
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Pin, fixation, smooth.
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Bit, drill.
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Reamer.
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Arthroscope.
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. Plate, fixation, bone.
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessori
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.
June 1, 2016Medical DevicesFDA
Biomet, Inc. recalls Various trauma and sports medicine instruments and implants. guide, surgical, instrument
Hazard: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.