—#216348

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.

FDA product code: JDS — Nail, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K201336, K201346
Affected lot / code info: Product Code: 04.045.346TS. GTIN: 10886982301413. Lot Number: 31756P7. Expiration Date: 08/31/2025

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

DePuy Synthes notified consignees via email and mailed letter on 09/26/2025. Consignees were instructed to examine inventory and quarantine affected units, arrange for the return of any affected units, complete and return the Business Response Form, and place the notification in a visible area for awareness. If units were further distributed within your facility or to customers, please notify those customers and personnel.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-09-26
Posted by FDA: 2025-10-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216348. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.