Tornier, Inc. Recalls Reversed Peripheral Screws Due to Labeling Error

What Happened

Tornier, Inc. has initiated a voluntary recall of a specific lot of its Perform Reversed Peripheral Screws. The recall was prompted by a labeling error where screws labeled as 5.0mm x 18mm were found to actually be 5.0mm x 14mm. This discrepancy was discovered after the products were distributed.

Which Products Are Affected

The recall affects the following medical device:

• Product Name: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE
• Catalog Number: DWJ318
• Lot Number: AZ4824290
• Quantity: 427 units
• Distribution: Nationwide across the United States.

What You Should Do

Tornier, Inc. began notifying customers via a formal letter on December 19, 2025. Healthcare facilities and surgical centers should immediately check their inventory for Lot AZ4824290. Affected products should be quarantined and handled according to the instructions provided by the manufacturer. Surgeons who may have used these screws should be aware of the potential for mechanical issues in patients.

Why This Matters

The use of an incorrectly sized screw can lead to significant clinical complications. If the mismatch is identified during a procedure, it may cause surgical delays. If the incorrect screw is implanted, it increases the risk of early mechanical failure, loosening of the hardware, and the potential necessity for revision surgery.

Source

Information provided by the FDA. Recall Number: Z-1237-2026.