Recall Z-0014-2014 ยท HWC Screw, Fixation, Bone
Synthes USA HQ, Inc.
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.
| Date | Oct 17, 2013 (initiated Mar 8, 2013) |
| Status | Terminated |
| Reason | 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 | Labeling design |
| Action | 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. |
| Quantity | 62 |
| Distribution | Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081071 | SYNTHES 6.5MM MIDFOOT FUSION BOLT Synthes (Usa), May 1, 2008 |