—#121016

Product

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.

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K081071
Affected lot / code info: Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547.

Why it was recalled

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.

Root cause (FDA determination)

Labeling design

Action the firm took

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.

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 MI, PA, SC, IA, MA, CA, WI, IL, and KS.

Timeline

Recall initiated: 2013-03-08
Posted by FDA: 2013-10-17
Terminated: 2015-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.