—#113797

Product

Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening.

FDA product code: KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K082650
Affected lot / code info: Part number 390.007, Lot number 6800599

Why it was recalled

The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Synthes sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated September 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were asked to complete and return a Verification Form via fax to 610-251-9005. Contact the firm at 610-719-5450 for questions regarding this notice.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution-including the states of CA, MN, NC, and TN.

Timeline

Recall initiated: 2012-09-28
Posted by FDA: 2012-11-13
Terminated: 2015-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #113797. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.