Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large
FDA device recall Z-0014-2014 · posted 2013-10-17 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- 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 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 62
- Distribution
- Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.
- Date initiated
- 2013-03-08
- Date posted
- 2013-10-17
- Date terminated
- 2015-08-12
- Location
- West Chester, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES 6.5MM MIDFOOT FUSION BOLT (K081071) | Synthes (Usa) | 2008-05-01 |