—#178990

Product

WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222

FDA product code: KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060731
Affected lot / code info: Lot code 1633303

Why it was recalled

Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.

Root cause (FDA determination)

Process control

Action the firm took

The firm initiated the recall by email and letter on 12/27/2019. The notices requests the following actions: Immediately quarantine all recalled products they have and return all affected product to Wright Medical as soon as possible. If they have further distributed the affected product, we are asking them to notify the applicable parties at once about this recall. They may copy and distribute the notification letter and Wright Medical will work directly with them to collect the recalled items.

Recalling firm

Firm: Wright Medical Technology, Inc.
Address: 1023 Cherry Rd, Memphis, Tennessee 38117-5423

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2019-12-27
Terminated: 2021-07-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178990. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.