Agency classClass IIOur severity:High FDA (Devices)·Z-1168-2017·Announced 2017-03-01

Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

Biomet U.K., Ltd. is recalling Oxford Unicompartmental Knee Phase 3 Shim Size 3 instruments due to potential alumina inclusions that could cause cracking and separation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a structural defect (cracking and separation) in a surgical instrument, which poses a risk of harm during use, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Biomet U.K., Ltd. is conducting a medical device field action for specific lots of Oxford Knee instruments. The affected products are the Oxford Unicompartmental Knee Phase 3 Shim Size 3, which are instruments used with the Oxford Uni Partial Knee System. A total of 72 units are involved in this recall.

The recall is being conducted due to potential alumina inclusions in the raw material batch used to produce the affected products. These inclusions contained within the finished product could lead to the cracking and separation of the instrument.

The affected lots are ZB160601 and ZB160701, with item number 32-420665. The products were distributed worldwide, including in the United States states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, and NJ, as well as in Thailand, Japan, and the Netherlands. Healthcare providers and facilities should stop using the affected instruments and contact Biomet for further instructions.

The recalled product

Product: Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Manufacturer: Biomet U.K., Ltd.
Category: Medical Device — Surgical Instruments
Hazard: structural-defect
cracking
separation
Affected units: 72

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Item:32-420665
Lots: ZB160601
ZB160701

Distribution

Distributed in 14 states:

Part of a larger recall action

This product is one of 24 recalled by Biomet U.K., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 24 products in this recall →

Same manufacturer · Biomet U.K., Ltd.

See all →

High
Biomet Oxford Knee Instruments Recalled for Material Inclusions
FDA (Devices) · 2017-03-01
High
Biomet Oxford Knee Instruments Recalled for Potential Material Inclusions
FDA (Devices) · 2017-03-01
High
Biomet Recalls Oxford Knee Instruments Due to Material Inclusions
FDA (Devices) · 2017-03-01
High
Biomet Oxford Partial Knee Instruments Recalled for Material Inclusions
FDA (Devices) · 2017-03-01
High
Biomet Recalls Oxford Knee Instruments Due to Material Inclusions
FDA (Devices) · 2017-03-01

Same hazard · structural defect