FDA Medical devices recall ·
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small… recall
- Recall number
- Z-1769-2026
- Date
- (initiated March 5, 2026)
- Company / brand
- Tornier, Inc
10801 Nesbitt Ave S, Bloomington, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 233
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Idaho Illinois Indiana Kentucky Massachusetts Minnesota Missouri North Carolina Nebraska New Hampshire New Jersey Nevada New York Ohio Oklahoma Oregon Pennsylvania South Dakota Tennessee Texas Utah Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1769-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.