Orthopedic implant recall due to labeling mismatch on Stryker EVOLVE Proline Stem
Wright Medical Technology recalls 32 units of Stryker EVOLVE Proline Stem due to labeling mismatch: outer packages are labeled with one stem size but contain a different size. Surgeons should verify device size before implantation.
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: FDA Class II labeling error on a risk-of-harm product (orthopedic implant) where size mismatches could potentially cause serious surgical or patient complications. No injuries have been reported to date, keeping the score below Severe.
Plain-English summary
Wright Medical Technology, Inc. is recalling 32 units of the Stryker EVOLVE Proline Stem, an orthopedic device used in radial head repair surgery.
The recall was initiated due to a labeling mismatch: packages labeled with one size contain a stem of a different size. Specifically, packages labeled "EVOLVE Proline Stem 7.5mm +2" contain a "9.5mm +4" stem, and packages labeled "EVOLVE Proline Stem 9.5mm +4" contain a "7.5mm +2" stem. The affected lot number is 1704255 (UDI-DI: (01)008404201856775(11)210831(17)290829).
The devices were distributed nationwide in the United States. No injuries or adverse events have been reported. Surgeons who received this product should verify the actual stem size before implantation to ensure the correct device is used.
Contact Wright Medical Technology, Inc. for assistance with this recall.
The recalled product
- Product
- stryker EVOLVE, Proline Stem, CoCr, Size: +4, OD: 9.5mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and Repair System is a set configuration designed to address radial head fractures. It combines parts of two systems: EVOLVE Proline and EVOLVE TRIAD.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 32
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 (1)
- UDI/DI: (01)008404201856775(11)210831(17)290829 Lot Number 1704255
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Wright Medical Technology, Inc. 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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