Recall Z-1466-2023
Wright Medical Technology, Inc. · initiated April 10, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
Codes / lots: UDI/DI 00889797101011, Lot Number 1736809
Reason for recall
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
FDA-determined cause: Employee error
Action taken
The firm issued an URGENT: MEDICAL DEVICE RECALL notice to its sales representatives and distributors on 04/10/2023 by email and followed with letters disseminated to the remaining consignees via tracked FedEx mailing on Wednesday, April 12. The notice explained the issue and the risk and requested the following actions be taken: Identify all affected products and isolate/quarantine to prevent accidental use. All parties that further distributed the product were directed to notify anyone to the recipients of the affected products. The firm is seeking return of the products.
Details
- Recall number
- Z-1466-2023
- Initiated
- April 10, 2023
- Posted by FDA
- April 26, 2023
- Product code
- HRS – Plate, Fixation, Bone
- Quantity
- 41 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Wright Medical Technology, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1467-2023 Class II | stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixationTwo lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. | 04/10/2023Open, Classified |