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.
August 18, 2021Medical DevicesFDA
Biomet, Inc. recalls Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
Hazard: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
August 18, 2021Medical DevicesFDA
Biomet, Inc. recalls Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
Hazard: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
August 18, 2021Medical DevicesFDA
Biomet, Inc. recalls Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
Hazard: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
August 18, 2021Medical DevicesFDA
Biomet, Inc. recalls Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
Hazard: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
August 18, 2021Medical DevicesFDA
Biomet, Inc. recalls Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Hazard: Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention
February 24, 2021Medical DevicesFDA
Biomet, Inc. recalls Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis ass
Hazard: Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw.
January 27, 2021Medical DevicesFDA
Biomet, Inc. recalls A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation o
Hazard: The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
December 30, 2020Medical DevicesFDA
Biomet, Inc. recalls Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item
Hazard: Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323230, 31-323240 - Product Usage: Bit, Drill.
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation.
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Product Usage: Prosthesis, Hip, Semi-Constrain
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthe
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 14-405044, 14-405070 - Product Usage: Fractu
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral comp
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in limb salvage procedures.
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: 1. Noninflammatory degenerative joint dise
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical ins
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 18
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929, 1100
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 11000
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
December 23, 2020Medical DevicesFDA
Biomet, Inc. recalls 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009787 110009790,
Hazard: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
October 21, 2020Medical DevicesFDA
Biomet, Inc. recalls (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM:
Hazard: Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.
October 21, 2020Medical DevicesFDA
Biomet, Inc. recalls Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 01000058
Hazard: Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters
October 14, 2020Medical DevicesFDA
Biomet, Inc. recalls Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Hazard: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
October 14, 2020Medical DevicesFDA
Biomet, Inc. recalls Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Hazard: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
October 14, 2020Medical DevicesFDA
Biomet, Inc. recalls Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
Hazard: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
October 14, 2020Medical DevicesFDA
Biomet, Inc. recalls Biomet Regenerex Primary Taper Cap Item Number 141269
Hazard: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized