Tornier recalls 233 surgical parts nationwide in the United States. The items were mislabelled as Tornier HRS Max products. These parts fit the Tornier HRS system only and are incompatible with the Tornier HRS Max system. Clinicians and patients should stop using the affected parts and follow recall instructions.
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.
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
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Tornier makes orthopedic surgical tools and implants. HRS and HRS Max are modular system components used in procedures requiring bone reconstruction.
Mislabeling makes it unclear which system the parts fit. Incompatibility could lead to improper usage or device failure during procedures.
This recall is not explicitly indicating a broader pattern in mislabeling for Tornier products, based on the provided information.
Clinicians must verify compatibility to avoid using wrong components. Potential risk is procedural delay or device mismatch with patient safety implications.
Recall letter from Tornier and FDA enforcement page linked in the notice.
Replacement or refund processing timelines are determined by Tornier and may follow standard recall timelines.
Keep recall letter, GTINs, model numbers, lot numbers, and any communications with Tornier.
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.
No specific injuries or incidents are listed in the provided recall notice.
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