—#119840

Product

Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.

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

It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.

Root cause (FDA determination)

Packaging

Action the firm took

Synthes sent a Urgent Notice Medical Device Recall letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is requesting that you please examine your inventory for products with the above Part and Lot number and remove them. Call Synthes at 1-800-479-6329. If you have any further questions please call 610-719-5450.

Recalling firm

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

Distribution

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

Timeline

Recall initiated: 2012-10-12
Posted by FDA: 2013-07-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119840. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.