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LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/… recallZ-0228-2026 · Synthes (USA) Products LLC · initiated Sep 26, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0228-2026
Status
Open, Classified
Initiated by the company
Sep 26, 2025
Posted by the FDA
Oct 21, 2025
Recalling firm
Synthes (USA) Products LLC
Quantity
120 units
Product code
JDS
FDA submissions
K201336, K201346
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 description

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.

Code information (models, lots, serial numbers)

Product Code: 04.045.346TS. GTIN: 10886982301413. Lot Number: 31756P7. Expiration Date: 08/31/2025

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

166 devices cleared under K201336, K201346 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97693).

Sources and updates

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