The Recall Desk
HighFDA (Devices)·Z-1163-2017·Announced 2017-03-01

Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

Biomet U.K., Ltd. is recalling Oxford Partial Knee System instruments due to potential alumina inclusions that could cause cracking and separation.

What this means for you

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 involves a risk-of-harm product (medical instrument failure) where injury has not yet been reported, fitting the criteria for a High severity score.

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 Oxford Partial Knee System Left Medial Tibial Trial Tray Size D instruments, used with the Oxford Uni Partial Knee System. A total of 72 units are involved in this recall.

The recall is being conducted because the raw material batch used to produce these instruments may contain alumina inclusions. These inclusions could lead to the cracking and separation of the finished instrument during use. The affected lots are ZB160501, ZB160601, and ZB160802, with item number 32-420734.

The products were distributed worldwide, including in the United States states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, and OK, as well as in Thailand, Japan, and the Netherlands. Healthcare providers and facilities should stop using these specific instruments and contact Biomet U.K., Ltd. for further instructions on the field action.

The recalled product

Product
Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Manufacturer
Biomet U.K., Ltd.
Category
Medical Device — Orthopedic Instruments
Hazard
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 (4)

  • Item: 32-420734
  • Lots: ZB160501
  • ZB160601
  • ZB160802

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 →

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