Data / Medical devices / United Kingdom / Biomet Uk Ltd.
Biomet Uk Ltd.: FDA-registered device maker in Bridgend, United Kingdom, 3 510(k) clearances and 1 PMA approval
Biomet Uk Ltd. is registered with the FDA (registration 3002806535) in Bridgend, United Kingdom. It lists 25 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated July 29, 2020. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3002806535
- Address
- Waterton Industrial Estate, Bridgend, United Kingdom, CF31 3XA
- Owner or operator
- Zimmer Inc (1825034)
- Roles
- Specification developer
- First device listed
- December 28, 1977
- Registered through
- 2027
- Brand names listed
- ARCOS INTERLOCKING DISTAL STEMS, BIOMET, BIOMET AWL, BIOMET DRILL BIT, BIOMET GENERAL, BIOMET IMPACTOR, BIOMET OSTEOTOME, BIOMET SURGICIAL and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 29, 2020 | K200959 | Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling | LZO | Substantially Equivalent | Biomet UK, Ltd. | accessdata.fda.gov |
| May 1, 2015 | K150522 | G7 Dual Mobility System | LPH | Substantially Equivalent | Biomet, Inc. | accessdata.fda.gov |
| December 7, 2010 | K100469 | ARCOS INTERLOCKING DISTAL STEMS | KWA | Substantially Equivalent | Biomet Manufacturing Corp | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 21, 2004 | P010014 | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM | NRA | 107 | October 6, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 9, 2018 | 80921 | Class II | Terminated | HipLOC Hip Fracture Fixation System- Hiploc System 130 Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Speci | HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel | accessdata.fda.gov |
| January 5, 2016 | 76179 | Class II | Terminated | Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial Knee System | Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument. | accessdata.fda.gov |
| March 20, 2013 | 64679 | Class II | Terminated | REF 32-422760 Oxford Uni Knee System,Toffee Hammer, non-sterile, found in REF 32-422763 Oxford Mlcroplasty Knee System Tibial instrument Tray small surgical hammer supplied with the Oxford Partial Knee Microplasty Instru | Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle. | accessdata.fda.gov |
| July 27, 2012 | 62745 | Class II | Terminated | Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component. | A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in an increase of 1.0mm in the value of each dimension | accessdata.fda.gov |
| February 14, 2012 | 61274 | Not yet classified | Terminated | Vanguard Knee Instrumentation Distal Cutting Block without Handles, REF 32-487002 LOT 2561329, Biomet UK Ltd, South Wales, UK Used to guide a saw blade in resecting the the distal femor. Intended to be used with a femora | This recall was initiated following a report that a bag labeled as REF. 32-487557/Lot no 2561334 (Vanguard Tibial Resection head universal w/ alignment tower) actually contained a Ref. 32-487002/Lot no. 2561329 (Vanguard Distal cutting Block w/out handle attachment). Investigation found packaging of the affected product may contain the incorrect item. | accessdata.fda.gov |
| April 22, 2011 | 58702 | Not yet classified | Terminated | Oxford Femoral Knee System REF 154600, LOT 2272736, WARNING DO NOT RESTERILIZE, STERILE UNLESS PACK DAMAGED, BIOMET UK Ltd, (510K# K011138) This device is used in partial knee replacement surgery as a result of patients | This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to contamination of the device. | accessdata.fda.gov |
Compare with other makers
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Updated October 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.