Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for… recallZ-0014-2014 · Synthes USA HQ, Inc. · initiated Mar 8, 2013
Class II Terminated All recalls posted in October 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Synthes USA HQ, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Labeling design
What the company is doing
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.
Recall details
- Recall number
- Z-0014-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 8, 2013
- Posted by the FDA
- Oct 17, 2013
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 62
- Product code
- HWC
- FDA submissions
- K081071
- Distribution
- Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.
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.
Code information (models, lots, serial numbers)
Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547.
Other devices under the same FDA submission
1 device cleared under K081071 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 02.111.215Synthes GmbH · Screw, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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