Reported Apr 15, 2026 · Ongoing

Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max…

Tornier, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tornier, Inc · 10801 Nesbitt Ave S · Bloomington, MN · 55437-3109

Is this the product you have?

  • Tornier HRS Max parts1. 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
Lot codes and dates

3 of 3 products

Products covered by this recall
#BarcodesProduct as published
100840338603623UDI-DI (GTIN) 00840338603623 Lot Numbers AZ0124352 AZ0224352 AZ0324352 AZ0424352 AZ0524352
200840338603630UDI-DI (GTIN) 00840338603630 Lot Numbers AZ0624352 AZ0724352 AZ0824352 AZ0924352 AZ1024352
300840338604033UDI-DI (GTIN) 00840338604033 Lot Numbers AZ0124351 AZ0224351 AZ0524351 AZ0724351 AZ0924351
Amount recalled
233

Where it was sold

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.