Tornier HRS Max shoulder implant parts recalled for incorrect labeling and incompatibility
Tornier, Inc. recalled three shoulder implant parts that were incorrectly labeled as compatible with the Tornier HRS Max system. These parts actually work only with the older Tornier HRS system and will not fit properly in HRS Max procedures. A total of 233 units with specific lot numbers were distributed nationwide.
From the FDA notice · Read the official notice ↗
What to do
- If you received or implanted any of these parts, verify the lot number against the FDA notice (lot numbers starting with AZ0124352, AZ0224352, etc.)
- Contact your Tornier, Inc. representative or the distributor immediately if you have affected inventory
- Do not use these parts in Tornier HRS Max procedures
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 233
- Illnesses reported
- None reported
- Manufactured in
- 10801 Nesbitt Ave S, Bloomington, MN, United States
- Classification
- Class II
- Recall number
- Z-1769-2026
In the FDA's words
- Description
- 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 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. 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 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. Affected quantity: 233
- 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.