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.
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- May 29, 2013
- Posted
- November 26, 2013
- Terminated
- May 21, 2015
- Recall Number
- Z-0401-2014
- Quantity
- 1
- Firm Location
- West Chester, PA
Reason for Recall
A plate was inadvertently released to a sales consultant that was restricted for sale.
Distribution
US Distribution in Colorado.
Lot / Code Info
part 04.124.406S, lot 3771678.
Root Cause
Employee error
Action Taken
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.
More recalls by Synthes Usa (Hq), Inc.
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012
The Synthes Electric Pen Drive is...
Dec 31, 2013
Synthes Trochanteric Fixation Nail
As part of the Synthes Trochanteric Fixation Nail (TFN) System,...
Dec 10, 2013
Synthes TomoFix Plates
The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wed...
Dec 10, 2013