Reported Oct 12, 2022 · Ongoing
stryker EVOLVE, Proline Stem, CoCr, Size: +2, O: 705mm, REF 496S275, Wright s EVOLVE Proline Plus Radial Head and…
Wright Medical Technology, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wright Medical Technology, Inc. · 1023 Cherry Rd · Memphis, TN · 38117-5423
Is this the product you have?
- stryker EVOLVE, Proline Stem, CoCr
- Size+2, O: 705mm, 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 systemsEVOLVE Proline and EVOLVE TRIAD
- Lot codes and dates
- UDI/DI(01)00840420185877(11)210107(17)290105 Lot Number 1704691
- Amount recalled
- 16 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The outer label does not match the device inside the package. The affected lot of EVOLVE Proline Stem 7.5mm +2 contains a size 9.5mm +4 stem, while the affected lot of EVOLVE Proline Stem 9.5mm +4 contains a size 7.5mm +2 stem.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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