Recall Z-1467-2023 ยท HRS Plate, Fixation, Bone
Wright Medical Technology, Inc.
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
| Date | Apr 26, 2023 (initiated Apr 10, 2023) |
| Status | Open, Classified |
| Reason | Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 50 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120359 | ORTHOLOC 3DI HALLUX SYSTEM Wrightmedicaltechnologyinc, May 3, 2012 |