—#123143

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.

FDA product code: JDP — Condylar Plate Fixation Implant
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K110354
Affected lot / code info: part 04.124.406S, lot 3771678.

Why it was recalled

A plate was inadvertently released to a sales consultant that was restricted for sale.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: US Distribution in Colorado.

Timeline

Recall initiated: 2013-05-29
Posted by FDA: 2013-11-26
Terminated: 2015-05-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #123143. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.