510(k) Report

FDA applicant

Biomet UK, Ltd.

Brigend, GB3 decisions2014–20204 recalls

FDA records 3 decisions for Biomet UK, Ltd. (Brigend, GB) from 2014 to 2020: 3 510(k) clearances. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and HRY (Prosthesis, Knee, Femorotibial…). Its devices cite 5 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Biomet UK, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2014: 12020: 2
2014high 2 (2020) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2022

2016: 12020: 22022: 1
2014high 2 (2020) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Biomet UK, Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biomet UK, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Biomet”

FDA records each applicant name separately; these may or may not be the same firm.