FDA DevicesClass II
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Ca...
Published: April 15, 2026Recall ID: Z-1769-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Bloomington |
| State | MN |
| Event id | 98512 |
| Address 1 | 10801 Nesbitt Ave S |
| Code info | 1. UDI-DI (GTIN) 00840338603623 Lot Numbers AZ0124352 AZ0224352 AZ0324352 AZ0424352 AZ0524352 2. UDI-DI (GTIN) 00840338603630 Lot Numbers AZ0624352 AZ0724352 AZ0824352 AZ0924352 AZ1024352 3. UDI-DI (GTIN) 00840338604033 Lot Numbers AZ0124351 AZ0224351 AZ0524351 AZ0724351 AZ0924351 |
| Postal code | 55437-3109 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 233 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260305 |
| Initial firm notification | Letter |
| Center classification date | 20260403 |
Overview
- Recalling FirmTornier, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.