Z-1125-2014Class II

Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate...

Name: Z-1125-2014 Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate...
Creator: Synthes, Inc.
Published: 2014-02-05
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-02-05 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle... on 2014-02-05. FDA classified it as Class II and gives the reason as "Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate...". 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-1125-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-05
Posted: 2014-03-04
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
Product: Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable locking capacity throughout the length of the plate shaft.
Product code: JDP Condylar Plate Fixation Implant
Reason for recall: Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert).
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Synthes sent an Urgent Field Safety Notification/Medical Device Labeling Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Exchage the previously shipped package insert (GP0006) with the correct package insert (GP2848 provided with the notification). Review the package insert. Forward the Field Safety Notification to anyone in their facility that needs to be informed. If the package insert has been forwarded to another facility, contact that facility. Maintain awareness of this notice until all package inserts have been exchanged. Maintain a copy of the notice. Customers with questions were instructed to maintain a copy of the notice. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 45
Distribution: Nationwide Distribution including GA, CA, TX, MO, OH, PA, WA, AL, IN, AZ, MI, IA, TN, KY, NC, VA, NY, LA, IL, UT, and KS.
Product codes and lots: part no. 02.231.240, lot no. 823111

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1125-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1125-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04

Product code JDP

K110354Class II4.5Mm Va-Lcp Curved Condylar Plate SystemSynthes USA / cleared 2011-03-04

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)