Medical Device Recall: Z-0014-2014

FDA Recalls dataset · Firm: Synthes USA HQ, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2013-03-08 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0014-2014.

Recall Res Number
Z-0014-2014
Recalling Firm / Manufacturer
FEI Number
3005180112
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2013-03-08
Date Posted
2013-10-17
Date Terminated
2015-08-12
Product Code
HWC
Event Number
65955
Product Quantity
62
Product Description 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.

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.

Action Details 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.

Distribution Pattern Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.

Code Information / Serial Numbers Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547.

Related Establishments / Registrations

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