The Recall Desk
HighFDA (Devices)·Z-1154-2017·Announced 2017-03-01

Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

Biomet U.K., Ltd. is recalling Oxford Knee 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 (instrument cracking/separation) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical risk.

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 Tibial Impactor, which are instruments used with the Oxford Uni Partial Knee System.

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 instrument during use.

A total of 72 units are affected, specifically Item 32-420932 from lots ZB160801, ZB160802, and ZB160803. 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 these specific instruments and contact Biomet for further instructions.

The recalled product

Product
Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Manufacturer
Biomet U.K., Ltd.
Category
Medical Device — Surgical 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: 32-420932
  • Lots: ZB160801
  • ZB160802
  • ZB160803

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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