stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
FDA device recall Z-1467-2023 · posted 2023-04-26 · Open, Classified
Recall details
- Recalling firm
- Wright Medical Technology, Inc.
- Reason for recall
- Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
- 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.
- Root cause
- Employee error
- Status
- Open, Classified
- Product code
- HRS
- Quantity affected
- 50 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-04-10
- Date posted
- 2023-04-26
- Location
- Memphis, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOLOC 3DI HALLUX SYSTEM (K120359) | Wrightmedicaltechnologyinc | 2012-05-03 |