UNITRAX Endoprosthesis Head Component - 42mm. recall: Labeling Error
UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
Why was UNITRAX Endoprosthesis Head Component - 42mm. recalled?
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 07613327032369 Lot Numbers: 4615EX, HE645D, 8A399N
- Product
- UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 18 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.
- Recall date
- July 24, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)