Tornier recalled 427 units of its Perform Reversed Perip Screws on December 19, 2025, due to incorrect labeling. The screws, meant to be 5.0mmx18mm, were misidentified as 5.00mmx14mm. This labeling issue can lead to surgical delays or increased risk of mechanical failure if unnoticed.
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
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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The recall affects catalog number DWJ318 of Tornier’s Perform Reversed Perip Screws. These non-sterile screws were distributed nationwide in the United States.
The incorrect labeling of the screws can result in delays during surgery if the mismatch is detected. If the incorrect screw is used without detection, patients may face risks of mechanical failure and the need for revision surgery.
Currently, there are no reported injuries or deaths linked to this labeling error. The recall is classified as Class II, indicating a high risk of injury.
Stop using the affected screws immediately. Healthcare providers should follow the recall instructions and contact Tornier, Inc. for further guidance.
For more information, patients and healthcare providers can contact Tornier, Inc. through the FDA's recall page.
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