—#115818

Product

Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: 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: Lot Numbers 6602070, 6582333, 6581191, and 6581193

Why it was recalled

The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Synthes sent an Urgent Notice: Medical Device Recall letter dated January 11, 2013 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to examine their inventory for the affected product(s), remove them from inventory and return them to Synthes. For questions call 610-719-5450 or email FieldAction@synthes.com

Recalling firm

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

Distribution

Distribution pattern: USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.

Timeline

Recall initiated: 2013-01-11
Posted by FDA: 2013-03-11
Terminated: 2015-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115818. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.