The Recall Desk

FDA (Devices) recall action 97693

Synthes (USA) Products LLC recalled 2 products on 2025-10-29

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2025-10-29
Critical
0
Units
242

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2025-10-29

    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.

    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.
    Category
    Distribution
    23 states
  • ModerateFDA (Devices)··2025-10-29

    Locking bone screws recalled after packaging labeled with the wrong length

    Synthes is recalling 122 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.

    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.
    Category
    Distribution
    23 states