The Recall Desk
HighFDA (Devices)·Z-1715-2013·Announced 2013-07-17

Biomet Recalls Oxford Fixed Bearing Partial Knee Components

Biomet is recalling 25 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 actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Biomet, Inc. is recalling 25 units of the Oxford Fixed Bearing Partial Knee, specifically the Cemented Lateral Tibia Size E3 (REF 154228). These medical devices are intended for use in the lateral compartment of the knee and are distributed worldwide, including in the United States (North Carolina, Indiana, Pennsylvania, and Ohio), Canada, and the Netherlands.

The recall was initiated after a Biomet investigation determined 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 characteristic poses a risk of harm to patients who have received or may receive these implants.

Healthcare providers and patients should contact Biomet for further instructions regarding the return or replacement of these devices. The recall number is Z-1715-2013.

The recalled product

Product
REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 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
25

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 (6)

  • M619800
  • M106200
  • M444870
  • M657020
  • M987640
  • M987330

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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