Recall Z-0401-2014
Synthes USA HQ, Inc. · initiated May 29, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: part 04.124.406S, lot 3771678.
Reason for recall
A plate was inadvertently released to a sales consultant that was restricted for sale.
FDA-determined 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.
Details
- Recall number
- Z-0401-2014
- Initiated
- May 29, 2013
- Posted by FDA
- November 26, 2013
- Terminated
- May 21, 2015
- Product code
- JDP – Condylar Plate Fixation Implant
- Quantity
- 1
- Distribution
- US Distribution in Colorado.
- Recalling firm
- Synthes USA HQ, Inc., West Chester, PA