Z-0401-2014Class II

Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar...

Name: Z-0401-2014 Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar...
Creator: Synthes USA HQ, Inc.
Published: 2013-05-29
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-05-29 / Terminated / root cause: manufacturing process

FDA source

Synthes USA HQ, Inc. began a recall of Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi... on 2013-05-29. FDA classified it as Class II and gives the reason as "A plate was inadvertently released to a sales consultant that was restricted for sale". 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-0401-2014
Classification: Class II
Status: Terminated
Initiated: 2013-05-29
Posted: 2013-11-26
Terminated: 2015-05-21
Recalling firm: Synthes GmbH
Product: Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
Product code: JDP Condylar Plate Fixation Implant
Reason for recall: A plate was inadvertently released to a sales consultant that was restricted for sale.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Synthes sent a letter dated November 7, 2013, to the implanting surgeon to follow up on a complaint received. The firm requested any additional information the surgeon might have about the use of the plate as well as a status on the patient following use. For questions the surgeon was instructed to call 800-620-7025. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 1
Distribution: US Distribution in Colorado.
Product codes and lots: part 04.124.406S, lot 3771678.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0401-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0401-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-26

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)