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.
December 24, 2014Medical DevicesFDA
Biomet, Inc. recalls Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal
Hazard: After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 34B Catalog Number: 51-199333, Lot Number Identification: 024320 and Sirius Polish Cemented Stem 38C, Catalog Number: 51-199335, Lot Number Identification: 141680, 180920.
October 22, 2014Medical DevicesFDA
Biomet, Inc. recalls Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses in
Hazard: An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
October 15, 2014Medical DevicesFDA
Biomet, Inc. recalls Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture t
Hazard: An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
October 15, 2014Medical DevicesFDA
Biomet, Inc. recalls Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through
Hazard: An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
October 15, 2014Medical DevicesFDA
Biomet, Inc. recalls Black Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through
Hazard: An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.
October 15, 2014Medical DevicesFDA
Biomet, Inc. recalls Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joi
Hazard: Investigation determined that units supplied were missing the 4x21 degree helix angle.
August 27, 2014Medical DevicesFDA
Biomet, Inc. recalls Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, B
Hazard: The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.
August 20, 2014Medical DevicesFDA
Biomet, Inc. recalls Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Commo
Hazard: The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.
July 2, 2014Medical DevicesFDA
Biomet, Inc. recalls DISCOVERY ELBOW prosthesis, 4 MM X 100 MM RIGHT HUMERAL FLANGED I BOND COAT Tl 6AL 4V ALLOY. Elbow
Hazard: Surface finish is different than specified. The implant has 30 grit blast on the exterior of the flange when the print calls for the glass bead blast. The patient may experience pain requiring surgical intervention.
June 25, 2014Medical DevicesFDA
Biomet, Inc. recalls G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500.
Hazard: Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
June 25, 2014Medical DevicesFDA
Biomet, Inc. recalls G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
Hazard: Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
June 25, 2014Medical DevicesFDA
Biomet, Inc. recalls EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing
Hazard: The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
June 25, 2014Medical DevicesFDA
Biomet, Inc. recalls EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use
Hazard: The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
June 25, 2014Medical DevicesFDA
Biomet, Inc. recalls EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, si
Hazard: The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
May 21, 2014Medical DevicesFDA
Biomet, Inc. recalls ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Hazard: This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.
March 26, 2014Medical DevicesFDA
Biomet, Inc. recalls Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique an
Hazard: Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.
March 26, 2014Medical DevicesFDA
Biomet, Inc. recalls Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and
Hazard: Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.
March 26, 2014Medical DevicesFDA
Biomet, Inc. recalls Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to cor
Hazard: Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was identified as CAM Assembly.
January 22, 2014Medical DevicesFDA
Biomet, Inc. recalls Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Hazard: 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
January 1, 2014Medical DevicesFDA
Biomet, Inc. recalls G7 Acetabular Screw 6.5mmx35mm Part Number: 010001000
Hazard: Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. The screw is actually a 6.5mm diameter and correctly corresponds to the items number on the label.
December 25, 2013Medical DevicesFDA
Biomet, Inc. recalls outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Single Use Gamma Sterilized, Rx inner incorr
Hazard: Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906760 7mm Medium.
December 4, 2013Medical DevicesFDA
Biomet, Inc. recalls REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Us
Hazard: Security Blades were manufactured oversized and potentially won't advance or may be difficult to advance through the mating Security Clip.
November 27, 2013Medical DevicesFDA
Biomet, Inc. recalls Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are in
Hazard: Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion.
July 17, 2013Medical DevicesFDA
Biomet, Inc. recalls REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for us
Hazard: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
July 17, 2013Medical DevicesFDA
Biomet, Inc. recalls REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy Only for us
Hazard: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
July 17, 2013Medical DevicesFDA
Biomet, Inc. recalls REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for us
Hazard: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
July 17, 2013Medical DevicesFDA
Biomet, Inc. recalls REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / CO-CR-MO Alloy Only for us
Hazard: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
July 17, 2013Medical DevicesFDA
Biomet, Inc. recalls REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use
Hazard: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
July 17, 2013Medical DevicesFDA
Biomet, Inc. recalls REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy Only for us
Hazard: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
July 17, 2013Medical DevicesFDA
Biomet, Inc. recalls REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use
Hazard: Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.