Z-1574-2016Class II

5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for...

Name: Z-1574-2016 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for...
Creator: Synthes (USA) Products LLC
Published: 2016-04-04
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-04-04 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones on 2016-04-04. FDA classified it as Class II and gives the reason as "This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1574-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-04
Posted: 2016-04-27
Terminated: 2016-09-02
Recalling firm: Synthes (USA) Products LLC
Product: 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
Product code: HWC Screw, Fixation, Bone
Reason for recall: This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DePuy Synthes mailed to customers an Urgent Notice informing them they were voluntarily recalling 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm-Sterile, part # 02.221.462S, Lot # 5539094, expiration date May 31, 2012, due to the units being shipped after the expiration date of May 31, 2012. Customers were instructed to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section on page 3 by checking the appropriate box and return the form and product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132.
Quantity in commerce: 15 units
Distribution: Distributed in IL and IN.
Product codes and lots: Lot Number 5539094, Catalog ID # 02.221.462S Manufacture date 07/02/2007 Expiration date 05/31/2012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1574-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1574-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-27

Product code HWC

K041533Class IISynthes (USA) [Synthes} Peri-Prosthetic ScrewsSynthes (Usa) / cleared 2004-09-01

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)