Screw Recall: Synthes locking screw 04.045.342TS
External labeling on the packaging for the low-profile locking screw is incorrect, with 42 mm items labeled as 46 mm and 46 mm items labeled as 42 mm. The etched length on the screws is correct. About 122 units were distributed worldwide, including US states AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and Canada (Lot 31756P9; Product Code 04.045.342TS; GTIN 10886982301390; Expiration 08/31/2025); recall conducted by FDA.
| Brand | Synthes (USA) Products LLC |
|---|---|
| Product | LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 42MM / XL25/ STER. Product Code: 04.045.342TS. Used in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail Advanced System. |
| Reason | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. |
| Severity | moderate |
| Units affected | 77 |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use or implant any screws from this lot that were labeled incorrectly.
- Contact your surgeon or medical facility for guidance and to determine if replacement or monitoring is needed; preserve packaging and recall details for reference.
- Follow any instructions provided by the manufacturer or FDA regarding recall actions and further steps.
How to identify the recalled item
| Lot / date codes | Product Code: 04.045.342TS. GTIN: 10886982301390. Lot Number: 31756P9. Expiration Date: 08/31/2025 |
|---|---|
| Lot / date codes | Part Number: 03.424.124-US. GTIN: 10886982335944. Lot Number: 68900P9. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.