Synthes Flexible Grip Recalled for Cleaning Limitations
Synthes USA is voluntarily recalling 328 Flexible Grip instruments from the Universal Nail System because they may not be thoroughly cleaned.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a medical device with a theoretical risk of inadequate cleaning, and the source text explicitly states no injuries or illnesses have been reported.
Plain-English summary
Synthes USA HQ, Inc. is initiating a voluntary recall of the Flexible Grip (Part number 355.28), which is part of the Synthes Universal Nail System. The recall involves 328 units distributed nationwide, including in states such as Arizona, California, and New York. The product is indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
The recall is being conducted due to the potential lack of ability to thoroughly clean the instrument. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers should stop using the affected Flexible Grip instruments immediately. Users should contact Synthes USA HQ, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 328
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 (2)
- Part number 355.28
- all lot numbers
Distribution
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