Recall Z-1291-2022 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Wright Medical Technology, Inc.
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle System.
| Date | Jun 2, 2022 |
| Status | Open, Classified |
| Reason | The instrument is incorrectly color coded. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued letters dated 2-June-2022 via email. The letter was issued to the distributors but the noticed was flagged to the attention of health care professionals, operators of medical devices, and distributors. The letter provided the product description, issue, potential risks, and actions needed as follows: (1) Immediately check the inventory to locate the product listed on the attached business reply form and remove it from its point of use; (2) Return the enclosed business reply form by email to confirm receipt of this notification and document product segregation; (3 |
| Quantity | 35 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IA, IL, MA, MI, MN, MO, NC, NY, OH, PA, TX, and WA. The countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Sweden, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140749 | INFINITY TOTAL ANKLE SYSTEM Wrightmedicaltechnologyinc, Apr 25, 2014 |