ClearanceBrief
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

CodeDeviceRecords
NRAProsthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing18
LXHOrthopedic Manual Surgical Instrument7
HWRDriver, Prosthesis2
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1
IQODevice, Prosthesis Alignment1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
LXHNone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
LXHNone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
LXHNone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
NRANone listed
Jan 5, 2016Biomet 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
HWRNone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
HWRNone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
LXHNone listed
Jan 5, 2016Biomet U.K., Ltd.
Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Terminated
LXHNone listed
Apr 15, 2013Biomet 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
NRANone listed
Aug 17, 2012Biomet 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
IQONone listed
Mar 19, 2012Biomet 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
LXHNone listed
Mar 19, 2012Biomet 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
LXHNone listed
Jun 29, 2011Biomet 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
HRYK011138
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