Synthes Midfoot Fusion Bolt Recall for Technique Guide Clarification
Synthes USA is recalling 62 Midfoot Fusion Bolts to update the technique guide, emphasizing supplemental fixation to reduce the risk of bolt back-out or migration.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Synthes USA HQ, Inc. is recalling 62 units of the Synthes Midfoot Fusion Bolt 6.5 mm. These medical devices are indicated for fracture fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle. The affected units are identified by Part Nos. 04.111.210, 04.111.220, and 04.111.230, with Lot Nos. ranging from 2294209 through 7587547.
The recall was initiated following a post-market safety review and several customer complaints. The review indicated that additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide. The updated guidance emphasizes the need for supplemental fixation to reduce the potential for bolt back-out or migration.
The affected products were distributed nationwide, including in the states of Michigan, Pennsylvania, South Carolina, Iowa, Massachusetts, California, Wisconsin, Illinois, and Kansas. Healthcare providers and facilities should review the updated technique guide and ensure supplemental fixation is used as recommended to mitigate the risk of device migration.
The recalled product
- 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.
- Manufacturer
- Synthes USA HQ, Inc.
- Affected units
- 62
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Part Nos.: 04.111.210
- 04.111.220
- 04.111.230. with Lot Nos.
- 2294209 through 7587547.
Distribution
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