Hip Prosthesis Component Mislabeled; Package Size May Not Match Device
Howmedica Osteonics is recalling 18 units of UNITRAX Endoprosthesis Head Components due to mislabeled package sizes. The label may not match the actual device size inside.
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: This is an FDA Class II medical device recall for mislabeled implantable prosthesis components with no reported illnesses or injuries. The label-to-device mismatch creates a risk of harm if a wrong-sized component is used, qualifying this as High severity per the rubric's criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Howmedica Osteonics Corp. is recalling 18 units of UNITRAX Endoprosthesis Head Component - 42mm (Catalog Number: 6942-5-042), an implantable component used in partial hip replacement surgery. The recall addresses a mislabeling issue in which the size printed on the package label potentially may not match the actual device contained within. This issue affects three sizes: 38mm, 42mm, and 43mm.
The affected products were distributed worldwide, including to locations in the United States, Australia, Hong Kong, and the United Kingdom. The affected Lot Numbers are 4615EX, HE645D, and 8A399N (GTIN: 07613327032369). Healthcare providers should verify the actual device size before use and contact Howmedica Osteonics Corp. for instructions regarding these recalled units.
Patients and healthcare providers with questions about this product should contact the manufacturer.
The recalled product
- Product
- UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 18
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 (3)
- GTIN: 07613327032369 Lot Numbers: 4615EX
- HE645D
- 8A399N
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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