Orthopedic implant head recall due to incorrect adapter in packaging
Biomet's Biolox ceramic hip implant heads were shipped with the wrong adapter component. The adapter had an incorrect neck length (M/+0 instead of S/-3.0) that differs in size marking.
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: This is an FDA Class II medical device recall for a risk-of-harm orthopedic implant where an incorrect component was shipped in packaging. Although no injuries have been reported, implanting the wrong adapter could compromise joint reconstruction. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
Biomet, Inc. is recalling Biolox Ceramic Option Head Zimmer 12/14 40mm -3 hip implant components due to a packaging error. One complaint reported that the product packaging contained an adapter with an incorrect neck length specification.
The adapter included had a neck length designation of M/+0, when the packaging should have contained an adapter with neck length specification S/-3.0. These adapters are distinguishable by size markings (S or M) on the device.
The recall affects 10 units that were distributed to healthcare facilities in nine U.S. states (Alabama, California, Maryland, Michigan, North Carolina, Ohio, Oklahoma, Tennessee, and Texas) and the Netherlands.
Patients or healthcare providers who have received this product should verify the adapter specifications match the packaging label before surgical implantation. Contact Biomet, Inc. for proper replacement or clarification regarding affected inventory.
The recalled product
- Product
- Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
- Manufacturer
- Biomet, Inc.
- Affected units
- 10
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 (2)
- UDI-DI: 00889024430556
- Lot Number: 3145299
Distribution
Part of a larger recall action
This product is one of 2 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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