Tornier Recalls Surgical Screws Over Labeling Error
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.
Quick Facts at a Glance
Recall Date
December 19, 2025
Hazard Level
HIGH
Brand
Tornier
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL
Hazard Information
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.
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
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About This Product
The Tornier Perform Reversed Perip Screw is a medical device used in orthopedic surgeries. Surgeons rely on these screws for stability and support during procedures.
Why This Is Dangerous
The screws are mislabelled, which can lead to the use of a shorter screw than intended. This mismatch can affect the integrity of surgical repairs.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience for healthcare providers who must replace the screws, leading to potential surgical delays.
Practical Guidance
How to identify if yours is affected
Locate the catalog number on the packaging.
Verify if the screws are labeled as 5.0mmx18mm.
Check your inventory for the affected lot number AZ4824290.
Where to find product info
The catalog number and lot number can typically be found on the product packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks after contacting Tornier, Inc.
If the manufacturer is unresponsive
Document all communication attempts with Tornier, Inc.
Consider reaching out to the FDA for further guidance.
Keep a record of your inventory and affected products.
How to prevent similar issues
Verify product labels before use in surgical settings.
Purchase from reputable suppliers with clear labeling practices.
Stay updated on recalls in the medical device industry.
Documentation advice
Keep records of purchase receipts, recall notifications, and any correspondence with Tornier, Inc.
Product Details
The recall affects catalog number DWJ318 of Tornier’s Perform Reversed Perip Screws. These non-sterile screws were distributed nationwide in the United States.
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