Company
Biomet U.K., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
29recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Unicompartmental Knee Phase 3 Shim Size 1
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
LXH | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Unicompartmental Knee Phase 3 Shim Size 2
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
LXH | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Unicompartmental Knee Phase 3 Shim Size 3
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
LXH | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Left Medial Tibial Trial Tray Size B
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Right Medial Tibial Trial Tray Size B
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Right Medial Tibial Trial Tray Size C
Oxford Partial Knee System Left Medial Tibial Trial Tray Size C Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Right Medial Tibial Trial Tray Size C
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Left Medial Tibial Trial Tray Size D
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Right Medial Tibial Trial Tray Size D
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Left Medial Tibial Trial Tray Size E
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Right Medial Tibial Trial Tray Size E
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Left Medial Tibial Trial Tray Size A
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Right Medial Tibial Trial Tray Size A
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Left Medial Tibial Trial Tray Size F
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Right Medial Tibial Trial Tray Size F
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
NRA | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
HWR | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Unicompartmental Knee Phase 3 Tibial Impactor
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
HWR | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Partial Knee System Femoral Slap Hammer
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
LXH | None listed |
| Jan 5, 2016 | Biomet U.K., Ltd. Oxford Knee System Tibial Resector Body Tube & Guides
Product Usage:
Instruments for use with the Oxford Uni Partial Knee System Terminated |
LXH | None listed |
| Apr 15, 2013 | Biomet U.K., Ltd. 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 Partia Terminated |
NRA | None listed |
| Aug 17, 2012 | Biomet U.K., Ltd. 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. Terminated |
IQO | None listed |
| Mar 19, 2012 | Biomet U.K., Ltd. Vanguard Knee Instrumentation Tibial Resection Tower Universal with alignment tower geometry, REF 32487557, LOT 2561334, Biomet UK Ltd, South Wales, UK
Product Usage: Usage: Used to guide a saw b Terminated |
LXH | None listed |
| Mar 19, 2012 | Biomet U.K., Ltd. 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 Terminated |
LXH | None listed |
| Jun 29, 2011 | Biomet U.K., Ltd. 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 Terminated |
HRY | K011138 |