Recall Z-1477-2024 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Wright Medical Technology, Inc.
stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
| Date | Apr 4, 2024 (initiated Mar 6, 2024) |
| Status | Open, Classified |
| Reason | Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing screw is used to lockout the Medial/Lateral adjustment on the INFINITY Resection Adjustment Guide. |
| Root cause | Process change control |
| Action | Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 03/06/2024 via email. The notice explained the issue, potential risk, and requested the consignee isolate/quarantine the affected product pending return of the device. If the affected product was further distributed, please notify the applicable parties at once about this recall. This notification letter may be copied and distributed. a. If possible, inform Stryker if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately |
| Quantity | 47 units |
| Distribution | US: TX, NE, and AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, COLOMBIA, FRANCE, GERMANY, ITALY, SPAIN, SWEDEN, SWITZERLAND, UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123954 | INFINITY TOTAL ANKLE SYSTEM Wrightmedicaltechnologyinc, Apr 1, 2013 |