FDA Recall
Terminated
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Recall: Z-1101-2020
·
Initiated December 27, 2019
Recall
- Recall Number
- Z-1101-2020
- Event Number
- 84673
- Firm
- Wright Medical Technology, Inc.
- FEI Number
- 3010667733
- Product Code
- KWI
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 27, 2019
- Terminated
- July 23, 2021
- Address
- 1023 Cherry Rd, Memphis, TN, 38117-5423
Description
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Reason
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.
Action
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.
Distribution
US
Quantity
39 devices