Buy me a coffee
Home › FDA recalls › Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body
CLASS II · ModerateFDA

Tornier, Inc recalls Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat

📅 Mar 5, 2026 · 📍 Nationwide
Recalling company
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 – may cause temporary or medically reversible health consequences
Recall date
Mar 5, 2026
Reported
Apr 15, 2026
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.
Status
Ongoing
Quantity
233
Lot / codes
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
Company location
Bloomington, MN
Recall type
Voluntary: Firm initiated
Recall number
Z-1769-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1769-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.