FDA Medical Device Recalls (openFDA)
Synthes (USA) Products LLC: 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.
- Recall number
- Z-0228-2026
- Recalling firm
- Synthes (USA) Products LLC
- 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.
- Status
- Open, Classified
- Initiated
- 2025-09-26
- Posted
- 2025-10-21
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 120 units
- 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.
- Lot, serial or model codes
- Product Code: 04.045.346TS. GTIN: 10886982301413. Lot Number: 31756P7. Expiration Date: 08/31/2025
- 510(k) numbers
- ["K201336","K201346"]
- PMA numbers
- not on file
- Product code
- JDS
- Firm FEI
- 3008812560
- Firm city
- West Chester
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28