The Recall Desk
SevereFDA (Devices)·Z-1167-2017·Announced 2017-03-01

Biomet Recalls Oxford Knee Instruments Due to Material Inclusions

Biomet U.K. is recalling Oxford Partial Knee instruments 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 agency classification is Class II, and the source describes a structural defect (cracking and separation) which poses a significant risk of injury during use, meeting the criteria for a Severe rating.

Plain-English summary

Biomet U.K., Ltd. is conducting a medical device field action for specific lots of Oxford Partial Knee System instruments. The recall involves 72 units of the Left Medial Tibial Trial Tray Size B, identified by item number 32-420730 and lots 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 affected instruments 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 U.K. for instructions on return or replacement. This is a Class II recall, indicating that use of or exposure to the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Oxford Partial Knee System Left Medial Tibial Trial Tray Size B 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:32-420730
  • 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 →

Related recalls

Same manufacturer · Biomet U.K., Ltd.

See all →

Same hazard · structural failure

See all →