Tornier, Inc: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
- Recalling firm
- Tornier, Inc
- 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
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-03-05
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/aa8d3d04-144f-4748-86bf-03378ee47e7f