Recall Z-0401-2014 ยท JDP Condylar Plate Fixation Implant
Synthes USA HQ, Inc.
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.
| Date | Nov 26, 2013 (initiated May 29, 2013) |
| Status | Terminated |
| Reason | A plate was inadvertently released to a sales consultant that was restricted for sale. |
| 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 | 1 |
| Distribution | US Distribution in Colorado. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110354 | 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM Synthes USA, Mar 4, 2011 |