UNITRAX Hip Implant Head Component Recalled for Package Label Size Mismatch
Howmedica Osteonics is recalling UNITRAX hip implant head components because the package label size may not match the device actually inside, potentially leading to incorrect surgical implantation. Affected units were distributed worldwide.
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 recall of a risk-of-harm medical device (orthopedic implant). The mislabeling poses potential for surgical error if the implanted component does not match the surgeon's surgical plan. No illnesses, injuries, or hospitalizations have been reported, which per the rubric keeps this at High (3) rather than Severe.
Plain-English summary
Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Component - 43mm, an implantable component used in partial hip arthroplasty. The recall affects 18 units that were distributed worldwide, including the United States, Australia, Hong Kong, and the United Kingdom.
The hazard is mislabeling on the product packaging. The size indicated on the package label may not match the actual size of the device inside the packaging. Three sizes are affected by this product mix: 43mm, 42mm, and 38mm. This mismatch poses a risk that a surgeon may implant an incorrect-sized component during hip replacement surgery.
Consumers and medical professionals who have received affected UNITRAX components should verify the actual device size matches the label before implantation. Affected lot numbers are 5Y1350, LN815R, and PV0H60 (GTIN: 07613327032376). Patients who have already received this implant should consult their orthopedic surgeon if they have concerns.
The recalled product
- Product
- UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
- 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: 07613327032376 Lot Numbers: 5Y1350
- LN815R
- PV0H60
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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