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.
FDA Recall Z-0401-2014 · Posted 2013-11-26
Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeJDP
Date Initiated2013-05-29
Date Terminated2015-05-21
Product Quantity1
Reason for Recall
A plate was inadvertently released to a sales consultant that was restricted for sale.
Firm 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.
Root Cause
Employee error
Distribution Pattern
US Distribution in Colorado.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.