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 26, 2012Medical DevicesFDA
Biomet, Inc. recalls EBI XFIX DFS Rail System (Adult Rail Gradual Swivel Clamp). The Biomet Rail System consists of a unilateral external fix
Hazard: It was reported that the number scale/graduation markings were missing on 14 pieces of the swivel clamp.
December 12, 2012Medical DevicesFDA
Biomet, Inc. recalls Bio-Modular Humeral Head 48mm x 24mm Ti 6AI4V/Ion Implanted (Orthopedic Implant) Product Usage: The OSS Knee Reamer
Hazard: The items in this lot are missing the ion implantation feature. The surface of the head may be softer and more prone to scratching, which in tum could potentially cause higher wear of the poly bearing. Increased wear could potentially lead to a shorter implant life.
December 12, 2012Medical DevicesFDA
Biomet, Inc. recalls OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are
Hazard: Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
December 12, 2012Medical DevicesFDA
Biomet, Inc. recalls OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are prim
Hazard: Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
December 5, 2012Medical DevicesFDA
Biomet, Inc. recalls Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1
Hazard: It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
November 28, 2012Medical DevicesFDA
Biomet, Inc. recalls Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell co
Hazard: The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
October 10, 2012Medical DevicesFDA
Biomet, Inc. recalls Optilock T15 AO Driver (3.5mm). Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of
Hazard: Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw
October 10, 2012Medical DevicesFDA
Biomet, Inc. recalls Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of
Hazard: Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw
September 26, 2012Medical DevicesFDA
Biomet, Inc. recalls JUGGERKNOT IN¿GUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole
Hazard: Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.