Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 5 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Biomet with 445 510(k) clearances and 279 device recalls. The most recent is a 510(k) clearance dated Jul 1, 2026: OSSTM Orthopedic Salvage System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 1, 2026 | OSSTM Orthopedic Salvage SystemK253434 · JDI | 510(k) clearances |
| May 19, 2026 | Taperloc® Complete Hip StemK251270 · LPH | 510(k) clearances |
| May 22, 2024 | Biomet Kirschner Wires (K-Wires)K241014 · HTY | 510(k) clearances |
| Dec 28, 2022 | StageOne™ Select Hip Cement Spacer MoldsK222760 · MBB | 510(k) clearances |
| Sep 15, 2022 | StageOne™ Shoulder Cement Spacer MoldsK221968 · MBB | 510(k) clearances |
| Sep 2, 2022 | StageOne Knee Cement Spacer MoldsK213287 · MBB | 510(k) clearances |
| Feb 7, 2022 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveK212431 · JDG | 510(k) clearances |
| Dec 10, 2021 | Comprehensive Humeral Fracture Positioning SleevesK212435 · KWS | 510(k) clearances |
| May 14, 2020 | A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary inteClass II · Distributed to the field without having completed design history files or design transfer activities | Device recalls |
| May 14, 2020 | A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation Class II · Distributed to the field without having completed design history files or design transfer activities | Device recalls |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fClass II · Distributed to the field without having completed design history files or design transfer activities | Device recalls |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temClass II · Distributed to the field without having completed design history files or design transfer activities | Device recalls |
| May 14, 2020 | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary intClass II · Distributed to the field without having completed design history files or design transfer activities | Device recalls |
| May 14, 2020 | A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary inteClass II · Distributed to the field without having completed design history files or design transfer activities | Device recalls |
| May 1, 2020 | Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003Class II · Device and tray that houses the device did not pass steam sterilization process validation testing | Device recalls |
| May 1, 2020 | Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235Class II · Device and tray that houses the device did not pass steam sterilization process validation testing | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
