Forty six millimetre locking screws recalled over wrong length on packaging
Synthes is recalling 120 low profile locking screws because 42mm screws were packaged and labeled as 46mm and 46mm screws were labeled as 42mm, though the etched length is correct.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the labeling-error criterion: the outer packaging states the wrong length while the screw itself is correctly etched, and no harm is reported.
Plain-English summary
Low Profile Locking Screws for intramedullary nails, 5.0mm, 46mm length, sterile, product code 04.045.346TS, used in the RFN-ADVANCED Retrograde Femoral Nailing System and the Tibial Nail Advanced System, are being recalled.
Although the etched length on the screw itself is correct, the length marked on the external packaging is incorrect: 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.
The recall covers 120 units carrying GTIN 10886982301413, lot 31756P7, expiring 31 August 2025. The product was distributed worldwide including nationwide in the United States. The FDA has classified the action as Class II.
Surgical teams should verify the etched length on the screw rather than relying on the outer packaging, and follow the firm's instructions.
The recalled product
- Product
- LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- mislabeling
- wrong-size
- packaging-error
Distribution
Distributed nationwide across the United States.
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