FDA recall, , Moderate risk
Tornier HRS Max Tuberosity Bodies and Trial
Tornier HRS Max parts were incorrectly labeled and are incompatible with the HRS Max system.
Summary by Recall Canary from the FDA notice
What happened
Tornier, Inc. of Bloomington, Minnesota recalled certain Tornier HRS Max parts because they were incorrectly labeled as Tornier HRS Max products and are incompatible with the Tornier HRS Max system. The affected parts are the TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101; the TORNIER HRS Max Tuberosity Body No Coat, Small, Cat.
No. ARS1041102; and the TORNIER HRS Max Trial, Cat. No. ARS10252. The recall began on March 5, 2026, and was added to the FDA's Enforcement Report on April 3, 2026.
Distribution was nationwide across 32 states, including Alabama, Arkansas, Arizona, California, and others.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Tornier HRS Max parts
- UDI-DI
- 00840338603623
- 00840338603630
- 00840338604033
- Lot code
- AZ0124352
- AZ0224352
- AZ0324352
- AZ0424352
- AZ0524352
- AZ0624352
- AZ0724352
- AZ0824352
- AZ0924352
- AZ1024352
- AZ0124351
- AZ0224351
- AZ0524351
- AZ0724351
- AZ0924351
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of 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.
- Company
- Tornier, IncBloomington, Minnesota
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98512
- Recall number
- Z-1769-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
