The Recall Desk
HighFDA (Devices)·Z-1701-2013·Announced 2013-07-17

Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

Biomet is recalling 24 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement between bone and the poly bearing.

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 device) where the hazard is a design flaw creating potential for impingement, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Biomet, Inc. is recalling 24 units of the REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4. These medical devices are partial knee replacement systems consisting of a femoral component and a fixed bearing tibial component intended for use in the lateral compartment of the knee with bone cement.

The recall was initiated after a Biomet investigation found that the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension. The affected units were distributed worldwide, including in the United States (North Carolina, Indiana, Pennsylvania, and Ohio), Canada, and the Netherlands.

Healthcare providers and patients who have received these specific components should contact Biomet, Inc. for further instructions regarding the recall and potential replacement or removal of the device.

The recalled product

Product
REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
24

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 (5)

  • M619750
  • M375480
  • M886380
  • M956060
  • M444700

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 30 recalled by Biomet, Inc. 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 30 products in this recall →

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