Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tubero
FDA device recall Z-1769-2026 · posted 2026-04-03 · Open, Classified
Recall details
- Recalling firm
- Tornier, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- KWS
- Quantity affected
- 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.
- Date initiated
- 2026-03-05
- Date posted
- 2026-04-03
- Location
- Bloomington, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Tornier Humeral Reconstruction System Max (Tornier HRS Max) (K251686) | Tornier, Inc. | 2025-10-30 |