Quick Facts at a Glance
- Recall Date
- March 5, 2026
- Hazard Level
- HIGH
- Brand
- Tornier
- Category
- Health & Personal Care
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Tornier
- Product type
- Tornier HRS Max surgical parts
- Model numbers
- 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
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 5, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Tornier, Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
Tornier makes orthopedic surgical tools and implants. HRS and HRS Max are modular system components used in procedures requiring bone reconstruction.
Why This Is Dangerous
Mislabeling makes it unclear which system the parts fit. Incompatibility could lead to improper usage or device failure during procedures.
Industry Context
This recall is not explicitly indicating a broader pattern in mislabeling for Tornier products, based on the provided information.
Real-World Impact
Clinicians must verify compatibility to avoid using wrong components. Potential risk is procedural delay or device mismatch with patient safety implications.
Practical Guidance
How to identify if yours is affected
- Check model numbers and GTINs: 00840338603623 with AZ lot numbers; 00840338603630 with AZ lots; 00840338604033 with AZ lots.
- Confirm compatibility with Tornier HRS or HRS Max systems according to the recall notice.
Where to find product info
Recall letter from Tornier and FDA enforcement page linked in the notice.
What timeline to expect
Replacement or refund processing timelines are determined by Tornier and may follow standard recall timelines.
If the manufacturer is unresponsive
- Document all communications.
- Escalate to manufacturer customer service and, if needed, file with consumer protection agencies.
How to prevent similar issues
- Verify labeling and compatibility before use.
- Request documentation confirming correct system compatibility before installation.
Documentation advice
Keep recall letter, GTINs, model numbers, lot numbers, and any communications with Tornier.
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Product Details
Quantity: 233 units. Distribution: Nationwide in 30+ states including 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. Model numbers/UDI-DI: 1) GTIN 00840338603623 with Lot AZ0124352 AZ0224352 AZ0324352 AZ0424352 AZ0524352; 2) GTIN 00840338603630 with Lot AZ0624352 AZ0724352 AZ0824352 AZ0924352 AZ1024352; 3) GTIN 00840338604033 with Lot AZ0124351 AZ0224351 AZ0524351 AZ0724351 AZ0924351. Remedial action: Stop using immediately. Notification by manufacturer via recall letter.
Reported Incidents
No specific injuries or incidents are listed in the provided recall notice.
Key Facts
- 233 units recalled nationwide
- Mislabeling as Tornier HRS Max parts
- Incompatible with HRS Max system
- Sold/distributed in 30+ states
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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