Recall Z-1769-2026 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Tornier, Inc
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252
| Date | Apr 3, 2026 (initiated Mar 5, 2026) |
| Status | Open, Classified |
| Reason | Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. |
| Root cause | Labeling design |
| Action | On March 5, 2026, the firm notified affected customers of the product issue. Customers were instructed to locate affected product in their inventory. Relevant personnel should be informed that the affected product must not be used with Tornier HRS Max products, as they are incompatible. Product return is not necessary, but customers may contact the recalling firm to arrange for return if the product issue impacts their needs. |
| Quantity | 233 |
| Distribution | US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) Tornier, Inc., Oct 30, 2025 |