FDA-Device2026-04-15Class IIMISBRANDING
Tornier HRS Max shoulder implant parts recalled for incorrect labeling and incompatibility
What this means
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.
- 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
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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 count
233
Manufactured in
10801 Nesbitt Ave S, Bloomington, MN, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1769-2026Want us to check the next one for you?
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