Recall Z-2105-2023 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Wright Medical Technology, Inc.
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
| Date | Jul 7, 2023 (initiated Jun 13, 2023) |
| Status | Open, Classified |
| Reason | The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes. |
| Root cause | Process control |
| Action | The firm issued a Field Safety Correction Action (FSCA) Medical Devices Vigilance System form to the lead competent authority, ANSM-France, via email on 6/13/2023 for their review and approval for the recall to be carried out in their jurisdiction. The FSCA identified the affected product, a description of the issue, and advice on actions to be taken by the distributor and the user. The advice included to check the inventory to locate the product listed and remove and isolate/quarantine it to prevent accidental use. A business reply form was to be returned by email to confirm receipt of th |
| Quantity | 106 devices |
| Distribution | There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123954 | INFINITY TOTAL ANKLE SYSTEM Wrightmedicaltechnologyinc, Apr 1, 2013 |