Tornier, Inc. Recalls Reversed Peripheral Screws Due to Labeling Error
Tornier, Inc. is recalling 427 surgical screws labeled as 18mm that are actually 14mm, posing risks of mechanical failure and revision surgery.
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.
Source: FDA Official Notice