UNITRAX Hip Endoprosthesis Head Components Mislabeled with Incorrect Package Sizes
Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Components because the package label size may not match the actual device inside. Mislabeling could result in the wrong implant size being used during hip surgery.
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 a Class II recall of an implantable surgical device where the package label may not match the actual device size, creating potential risk during hip surgery. No injuries or illnesses have been reported to date, but this constitutes a risk-of-harm product per FDA classification criteria.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific lots of the UNITRAX Endoprosthesis Head Component, an implantable device used in partial hip replacement surgery. The recall affects three component sizes: 38mm, 42mm, and 43mm, with lot numbers JT38AD and E94VEV.
The product label may display a size that does not match the actual device contained in the package. This mislabeling could result in an incorrect implant size being used during surgery.
The affected products have been distributed worldwide, including the United States, Australia, Hong Kong, and the United Kingdom. A total of 12 units are involved in the recall.
The recalled product
- Product
- UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 12
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)
- GTIN: 07613327032338 Lot Numbers: JT38AD
- E94VEV
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Howmedica Osteonics Corp. 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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