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.
This recall has been terminated (originally issued March 11, 2013).
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- January 11, 2013
- Posted
- March 11, 2013
- Terminated
- August 31, 2015
- Recall Number
- Z-0941-2013
- Quantity
- 136
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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.
Lot / Code Info
Lot Numbers 6602070, 6582333, 6581191, and 6581193
Root Cause
Nonconforming Material/Component
Action Taken
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