Z-1101-2020 Class II Terminated
FDA device recall Z-1101-2020 was initiated by Wright Medical Technology, Inc. on December 27, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated July 23, 2021). Affected quantity: 39 devices.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- December 27, 2019
- Termination Date
- July 23, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 devices
Product Description
WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220
Reason for Recall
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.
Distribution Pattern
US
Code Information
Lot Code 1633010