stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
- Company
- Wright Medical Technology, Inc.
- Recall Initiated
- April 10, 2023
- Posted
- April 26, 2023
- Recall Number
- Z-1466-2023
- Quantity
- 41 units
- Firm Location
- Memphis, TN
Reason for Recall
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI/DI 00889797101011, Lot Number 1736809
Root 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.