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Recall Observatory FDA recall evidence

Device 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

Z-1769-2026

March 05, 2026

Class II

Product summary

Firm
Tornier, Inc
Event
Event 98512
Status
Ongoing
Classification
Class II
Quantity
233
Official record key
device-enforcement:Z-1769-2026

Official wording

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.

Code information: 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 pattern: 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.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrectly labeled