Biomet

Complete recall history across all FDA and CPSC categories — 24 total recalls

Biomet appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (24)

FDA medical device enforcement actions by Biomet

Date Product Reason Class
May 14, 2020 Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Ite... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 14... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Ite... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number:... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 234... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 -... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item ... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Nu... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Ite... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90M... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Numbe... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 11001... Distributed to the field without having completed design history files or des... Class II
May 14, 2020 A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item... Distributed to the field without having completed design history files or des... Class II
May 1, 2020 Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Produ... Device and tray that houses the device did not pass steam sterilization proce... Class II
May 1, 2020 Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003 Device and tray that houses the device did not pass steam sterilization proce... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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