Z-0228-2026Class II

Low Prof Lckng Screw, F/im Nail 5.0Mm / L, 46Mm / Xl25/ Ster

Name: Z-0228-2026 Low Prof Lckng Screw, F/im Nail 5.0Mm / L, 46Mm / Xl25/ Ster
Creator: Synthes (USA) Products LLC
Published: 2025-09-26
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2025-09-26 / Open, Classified / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of 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... on 2025-09-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0228-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-26
Posted: 2025-10-21
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.
Product code: JDS Nail, Fixation, Bone
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Product Code: 04.045.346TS. GTIN: 10886982301413. Lot Number: 31756P7. Expiration Date: 08/31/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0228-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0228-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21
Z-0229-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-29	2025-10-21

Product code JDS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)