Lower risk Medical device recall · FDA · Published March 5, 2026

Tornier HRS Max Parts Recalled: Incompatible with Tornier HRS Max System

Tornier recalls specific HRS Max parts that are incompatible with the Tornier HRS Max system. These parts may cause system errors if used incorrectly. Affected products include Tuberosity Body Lat Coat and No Coat parts with specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1769-2026Medical device Tornier ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmTornier, Inc10801 Nesbitt Ave S · Bloomington, MN 55437-3109

✎ GovInfoNow plain-language explainer

Tornier is recalling certain HRS Max parts that are labeled incorrectly and are only compatible with the Tornier HRS system, not the Tornier HRS Max system. Using these parts with the HRS Max system could cause errors or malfunctions. Read more at govinfonow.com/recall/49790-tornier-hrs-max-parts-recalled-incompatible-with-tornier-hrs-max.

Source Summary by GovInfoNow · govinfonow.com/recall/49790-tornier-hrs-max-parts-recalled-incompatible-with-tornier-hrs-max · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1769-2026

Cite this page

“Tornier HRS Max Parts Recalled: Incompatible with Tornier HRS Max System.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49790-tornier-hrs-max-parts-recalled-incompatible-with-tornier-hrs-max. Based on FDA recall #Z-1769-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1769-2026%22&limit=1).

The FDA announced on March 5, 2026, that Tornier, Inc. is recalling Tornier HRS Max parts due to incorrect labeling that makes them incompatible with the Tornier HRS Max system. The agency issued recall number Z-1769-2026 for the voluntary Class II recall.

How to tell if you have it

Brand: Tornier
Product: TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101
Product: TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102
Product: TORNIER HRS Max Trial, Cat. No. ARS10252
UDI-DI (GTIN) 00840338603623 Lot Numbers AZ0124352 AZ0224352 AZ0324352 AZ0424352 AZ0524352
UDI-DI (GTIN) 00840338603630 Lot Numbers AZ0624352 AZ0724352 AZ0824352 AZ0924352 AZ1024352
UDI-DI (GTIN) 00840338604033 Lot Numbers AZ0124351 AZ0224351 AZ0524351 AZ0724351 AZ0924351
Units affected: 233

The hazard

According to the FDA, the affected products were incorrectly labeled as Tornier HRS Max products. The record states these parts are compatible with the Tornier HRS system only and are incompatible with the Tornier HRS Max system.

Context

GovInfoNow's records show Tornier, Inc has had 12 other recalls on record since Feb. 8, 2018. Other recent recalls include a Dec. 19, 2025 recall for incorrect labeling of Perip Screws and a March 3, 2025 recall for incorrect part marking of Latitude EV Humeral Revision Stem Trials. A prior Aug. 29, 2024 recall involved Stryker Tornier Perform Humeral System Reversed Inserts containing a locking ring assembled upside down.

How to tell if you have this one

Check for the product names: Tuberosity Body Lat Coat, Small (Cat. No. ARS1041101) or Tuberosity Body No Coat, Small (Cat. No. ARS1041102). Look for specific lot numbers listed in the recall notice.

Brand
Tornier
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Labels
Verify the product name and catalog number to confirm if it matches the recalled items.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 32 states.

FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Minnesota, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA published this recall 41 days after the firm started it.

Mar 5, 2026Firm started the recall
Apr 3, 2026FDA classified it Class II
Apr 15, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What specific lot numbers are affected?

Affected lot numbers include AZ0124352, AZ0224352, AZ0324352, AZ0424352, AZ0524352, and others as listed in the recall notice.

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Link to this recall

<a href="https://govinfonow.com/recall/49790-tornier-hrs-max-parts-recalled-incompatible-with-tornier-hrs-max">Tornier HRS Max Parts Recalled: Incompatible with Tornier HRS Max System (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1769-2026 (March 5, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1769-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.