The Recall Desk
HighFDA (Devices)·Z-1720-2013·Announced 2013-07-17

Biomet Recalls Oxford Fixed Bearing Partial Knee Components

Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.

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 medical device with a design defect that creates a potential for injury (impingement), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomet, Inc. is recalling 26 units of the Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia (REF 154235). These medical devices are designed for use in the lateral compartment of the knee and are intended to be implemented 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. This design issue poses a risk of harm to patients who have the device implanted.

The affected units were distributed worldwide, including in the United States (North Carolina, Indiana, Pennsylvania, and Ohio), Canada, and the Netherlands. Patients who have had this specific device implanted should contact their orthopedic surgeon to discuss the findings and determine the appropriate course of action.

The recalled product

Product
REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 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 t
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
26

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 (7)

  • M632970
  • M539450
  • M920610
  • M657090
  • M017520
  • M166860
  • M886420

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 →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · bone impingement

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