Z-0390-2014Class II

3.7mm and 5.0mm Dynamic Locking Screw (DLS)

Name: Z-0390-2014 3.7mm and 5.0mm Dynamic Locking Screw (DLS)
Creator: Synthes USA HQ, Inc.
Published: 2013-07-22
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-07-22 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates... on 2013-07-22. FDA classified it as Class II and gives the reason as "All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0390-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-22
Posted: 2013-11-26
Terminated: 2016-08-18
Recalling firm: Synthes GmbH
Product: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
Product code: HWC Screw, Fixation, Bone
Reason for recall: All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Synthes sent an Urgent Notice: Medical Device Recall letter to Sales Reps and End Users on July 22, 2013. The letter identified the affect product, problem and actions to be taken. For questions call the Recall center at 610-719-5450.
Quantity in commerce: 40248
Distribution: Worldwide Distribution - USA (nationwide) and internationally to Canada.
Product codes and lots: All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0390-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0390-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-25

Product code HWC

K110592Class II3.7Mm/5.0mm Dynamic Locking ScrewSynthes USA / cleared 2011-07-25

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)