Peripheral screws recalled after a lot was labeled the wrong length
Tornier is recalling 427 Perform Reversed peripheral screws because a lot labeled 5.0mm x 18mm actually contains 5.00mm x 14mm screws.
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: Scored 3 under the risk-of-harm criterion: the firm states an undetected mismatch may increase the risk of earlier mechanical failure, loosening and revision surgery, and no injuries are reported.
Plain-English summary
The Tornier Perform Reversed Perip Screw 5.0mm x 18mm non sterile, catalog number DWJ318, is being recalled by Tornier, Inc.
The record states a specific lot of screws is incorrectly labeled: the screws are labeled as 5.0mm x 18mm but the actual screws are 5.00mm x 14mm. The record states that if the mismatch is detected during surgery the issue may cause a minor delay in surgery, and that if it is not detected and the incorrect screw is used, the issue may increase the risk of earlier mechanical failure, loosening and the need for revision surgery.
The record lists 427 units from lot AZ4824290. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Facilities should quarantine the affected lot and follow Tornier's instructions.
The recalled product
- Product
- TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
- Manufacturer
- Tornier, Inc
- Affected units
- 427
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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