Recall Z-1102-2020
Wright Medical Technology, Inc. · initiated December 27, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
WRIGHT EVOLVE Proline Head, Size: +2, OD: 22mm, REF 496H222
Codes / lots: Lot code 1633303
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1102-2020
- Initiated
- December 27, 2019
- Terminated
- July 23, 2021
- Product code
- KWI – Prosthesis, Elbow, Hemi-, Radial, Polymer
- Quantity
- 48 devices
- Distribution
- US
- Recalling firm
- Wright Medical Technology, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1101-2020 Class II | WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and… | 12/27/2019Terminated |