Biomet Recalls Hip Implant Adapter Due to Wrong Specification in Packaging
Biomet is recalling a hip implant adapter lot due to incorrect packaging containing the wrong adapter specification. The mismatch could result in incorrect implant selection during surgery if not detected before use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall involving incorrect surgical implant adapter packaging. No reported injuries or illnesses, but the mismatch poses risk of harm through potential selection of wrong implant specification during surgical implantation.
Plain-English summary
Biomet, Inc. is recalling one lot of the Biolox Ceramic Option Head Zimmer 12/14 40mm +0 (Item Number 00-8777-040-02, Lot Number 3145300) due to incorrect adapter in product packaging. One complaint reported finding an adapter with neck length M/+0 inside the packaging instead of the correct specification S/-3.0. The difference in neck length is indicated by the size marker (S or M) on the device.
This is a U.S. Food and Drug Administration Class II medical device recall. Ten units from the affected lot were distributed to healthcare facilities in Alabama, California, Maryland, Michigan, North Carolina, Ohio, Oklahoma, Tennessee, and Texas, as well as the Netherlands.
The incorrect adapter specification in the packaging could result in the wrong implant component being selected for use during surgical implantation if the packaging error is not detected. Healthcare providers can verify the correct specification before use by checking the size indicator on the device.
The recalled product
- Product
- Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
- 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: 00889024430563
- Lot Number: 3145300
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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