What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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) and recall number Z-1769-2026, then follow Tornier, Inc's recall.

Has Tornier, Inc had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Tornier, Inc so far. Argus ingests new FDA enforcement records daily.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

FDA Class II Recall: Tornier HRS Max parts: 1. TORNIER HRS Max… by Tornier, Inc

Key facts

Recalling firm	Tornier, Inc
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	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
Classification	Class II
Recall number	Z-1769-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for 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.

The short version: Tornier, Inc recalled 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 on 2026-04-15. FDA classified this action as a Class II recall (recall number Z-1769-2026). Reason for 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.. Recall status: Ongoing. This is a device-category FDA recall record.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Tornier, Inc and the affected product is described in FDA's record as: 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. FDA's stated reason for the recall is: 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.. The recall is tracked under FDA recall number Z-1769-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 -- and the recall number Z-1769-2026. If it matches, stop using or distributing it and contact Tornier, Inc or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Tornier, Inc’s FDA history

Argus HQ has recorded 1 total FDA action tied to Tornier, Inc: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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) and recall number Z-1769-2026, then follow Tornier, Inc's recall.
Has Tornier, Inc had other FDA recalls or enforcement actions?: This is the only FDA action Argus HQ has on file for Tornier, Inc so far. Argus ingests new FDA enforcement records daily.
What is the FDA recall number for this event?: FDA recall number Z-1769-2026.
What is the current status of this recall?: Status as recorded by FDA: Ongoing.

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Full FDA history for Tornier, Inc

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). FDA Class II Recall: Tornier HRS Max parts: 1. TORNIER HRS Max… by Tornier, Inc — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-tornier-inc-z-1769-2026

MLA

"FDA Class II Recall: Tornier HRS Max parts: 1. TORNIER HRS Max… by Tornier, Inc — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-tornier-inc-z-1769-2026.

Chicago

Argus HQ Research. "FDA Class II Recall: Tornier HRS Max parts: 1. TORNIER HRS Max… by Tornier, Inc — Recall Details." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/recall/fda-recall-tornier-inc-z-1769-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_tornier_inc_z_1769_2026_2026,
  title = {FDA Class II Recall: Tornier HRS Max parts: 1. TORNIER HRS Max… by Tornier, Inc — Recall Details},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/recall/fda-recall-tornier-inc-z-1769-2026},
  note = {Accessed: August 29, 2026}
}

Source: FDA.gov — Recalls ↗