Biomet Oxford Fixed Lateral Knee Implants Recalled for Sterile Seal Breach
Biomet is recalling specific lots of Oxford Fixed Lateral knee implants because a breach in the sterile seal could lead to loss of sterility.
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 loss of sterility for an implanted medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Biomet, Inc. is recalling specific lots of Oxford Fixed Lateral knee implants (Item numbers 154330, 154370, 154373, and 154376). The recall involves 7,428 units distributed worldwide, including the United States, Argentina, Australia, Brazil, Canada, Chile, China, Costa Rica, EMEA, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, and Taiwan.
The reason for the recall is that specific lots of these sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to a loss of sterility of the device. The affected lots are 197660, 207230, 085200, and 155720.
These implants are indicated for use in the lateral compartment and are intended to be implanted with bone cement. Healthcare providers and patients should check their device lot numbers against the affected list. If a device is affected, it should not be used, and patients should contact their healthcare provider for further instructions.
The recalled product
- Product
- Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product Usage: indicated for use in the lateral compartment and intended to be implanted with bone cement.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 7,428
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 (1)
- Lots 197660 207230 085200 155720
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 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.
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