The Recall Desk
SevereFDA (Devices)·Z-1165-2017·Announced 2017-03-01

Biomet Recalls Oxford Partial Knee Trial Trays Due to Material Inclusions

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

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (cracking and separation) in a surgical instrument, which aligns with the rubric criteria for a Severe rating.

Plain-English summary

Biomet U.K., Ltd. is conducting a medical device field action for specific lots of the Oxford Partial Knee System Right and Left Medial Tibial Trial Tray Size C. The recall involves 72 units in total, identified by item number 32-420732 and lot numbers ZB160501, ZB160601, and ZB160801.

The action is being taken 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 product. The FDA has classified this as a Class II recall.

The affected 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 the affected instruments and contact Biomet for further instructions.

The recalled product

Product
Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C
Manufacturer
Biomet U.K., Ltd.
Category
Medical Device — Surgical Instrument
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:32-420732
  • Lots: ZB160501
  • ZB160601
  • ZB160801

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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