Wright Medical EVOLVE Proline Stem Labeling Error Recall
Wright Medical is recalling EVOLVE Proline Stem devices due to labeling errors where the outer package does not match the device inside. Affected devices are size-mismatched, which could lead to incorrect surgical placement.
What this means for you
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 recall with a risk-of-harm scenario (implantable surgical devices with size mismatch that could affect patient outcome), and no reported illnesses or injuries are stated in the source. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Wright Medical Technology, Inc. is recalling certain lots of EVOLVE Proline Stem devices that contain size-mismatched stems. 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. The outer label does not match the device inside the package.
These devices were distributed nationwide. Patients and healthcare providers who have received these devices should verify that the device specifications match the outer label before use. If discrepancies are identified, healthcare providers should contact Wright Medical Technology, Inc. immediately.
The recalled product
- Product
- 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 systems: EVOLVE Proline and EVOLVE TRIAD.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 16
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)00840420185877(11)210107(17)290105 Lot Number 1704691
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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