Synthes Large Buttress Compression Nut Recalled for Threading Defect
Synthes USA is recalling 135 Large Buttress Compression Nuts for Blade Guide Sleeve TFN because the nuts did not thread completely and became stuck.
What this means for you
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: The recall is classified as FDA Class II, and the source text describes a functional defect (stuck nut) without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Synthes USA HQ, Inc. is recalling 135 units of the Large Buttress Compression Nut For Blade Guide Sleeve TFN. This medical device is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof.
The recall was initiated due to complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck. The affected units are identified by Part # SD357.371 and specific lot numbers including 5734551, 6083065, 6538811, 6631975, 6703191, 6703190, and 6841538.
The product was distributed in the United States, including the states of Texas, Pennsylvania, New York, Georgia, Colorado, Indiana, American Samoa, Arkansas, Illinois, Michigan, Tennessee, California, Arizona, Mississippi, and Virginia. Healthcare providers should stop using the affected devices and contact Synthes USA HQ, Inc. for further instructions.
The recalled product
- Product
- Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 135
Distribution
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