[pending] TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
Pending LLM rewrite. Source: FDA_DEVICE Z-1237-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
- Manufacturer
- Tornier, Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot AZ4824290
Distribution
Distributed nationwide across the United States.
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