Recall Z-1169-2023 ยท HRS Plate, Fixation, Bone
Wright Medical Technology, Inc.
ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
| Date | Feb 24, 2023 (initiated Feb 2, 2023) |
| Status | Open, Classified |
| Reason | Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa. |
| Root cause | Employee error |
| Action | The firm issued an URGENT MEDICAL DEVICE notice to its the sole consignee by email on 02/02/2023. The notice explained the product and the issue and requested the following actions be taken: 1. Check inventory for affected product and remove from use 2, Sign and return the enclosed Business Reply Form by email to fieldaction@stryker.com to confirm receipt of this notification/documenting product disposition. Stryker will will contact you to arrange for the return of the affected device(s) 3. Maintain awareness of this communication internally until all required actions have been completed w |
| Quantity | 10 units |
| Distribution | US Nationwide distribution in the state of NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113014 | CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS Wrightmedicaltechnologyinc, Jan 31, 2012 |