Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
This recall has been terminated (originally issued October 17, 2013).
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- March 8, 2013
- Posted
- October 17, 2013
- Terminated
- August 12, 2015
- Recall Number
- Z-0014-2014
- Quantity
- 62
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.
Distribution
Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.
Lot / Code Info
Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547.
Root Cause
Labeling design
Action Taken
An "Urgent Notice: Medical Device Recall" letter dated March 8, 2013 was sent to customers asking them to check their inventory, remove all affected product technical guides from use, and return them to Synthes along with the Verification form. Customer questions were directed to (610) 719-5450.