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.
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 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- ModerateHowmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls Triathlon Universal Baseplate Finishing Trays Due to Moisture Risk
FDA (Devices) · 2026-10-21
- ModerateHowmedica Triathlon Instrument Trays Recalled for Sterilization Dry Time Issue
FDA (Devices) · 2026-10-21
- ModerateHowmedica Recalls TS Femoral Prep Trays Due to Sterilization Instructions
FDA (Devices) · 2026-10-21
- HighHowmedica Recalls Orthopaedic Implant Components Due to Material Aging
FDA (Devices) · 2026-09-23
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- HighCeramic Hip Femoral Head Component May Not Match Package Label
FDA (Devices) · 2022-04-06
- HighHip prosthetic femoral head component size and offset labeling mismatch
FDA (Devices) · 2022-04-06
- ModerateHowmedica Recalls Six Knee Prosthesis Units Due to Incorrect Size Labeling
FDA (Devices) · 2018-05-02
- HighExeter V40 Cemented Hip Stem Recalled for Potential Label Mix-Up
FDA (Devices) · 2022-02-23
- HighExactech hip prosthesis femoral head labeling and marking discrepancy
FDA (Devices) · 2021-08-18
- ModerateHip Reconstruction System Component Mislabeled for Size
FDA (Devices) · 2025-01-01