Amendia Recalls Optimus Fixed Awl Due to Tip Breakage During Surgery
Amendia, Inc. is recalling nine Optimus Fixed Awl devices because the tip broke after impaction during surgery. The devices were distributed to Florida, Georgia, Illinois, Missouri, and Texas.
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 medical device failure (tip breakage) during surgery, which presents a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Amendia, Inc. is recalling nine units of the Optimus Fixed Awl, a medical device used in surgical procedures. The recall was initiated after complaints were received indicating that the tip of the awl broke after impaction during surgery. The affected devices are identified by Part Number 139005 and Lot Number 182-16146.
The recalled devices were distributed in the United States to the states of Florida, Georgia, Illinois, Missouri, and Texas. The source text does not specify the number of patients affected or report any specific injuries resulting from the device failure.
Healthcare providers and patients who have used or possess this specific lot of the Optimus Fixed Awl should stop using the device and contact Amendia, Inc. for further instructions on how to proceed with the recall.
The recalled product
- Product
- Optimus Fixed Awl
- Manufacturer
- Amendia, Inc
- Affected units
- 9
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 (1)
- Part Number 139005 - Lot Number 182-16146
Distribution
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