Anspach MIA 16 Minimally Invasive Attachment Recalled for Sterility Failure
The Anspach Effort, Inc. is recalling 183 Anspach MIA 16 attachments because they did not reach the expected sterility assurance level.
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 3/5 (High).
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 that failed to meet sterility assurance levels, creating a risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Anspach Effort, Inc. is recalling 183 units of the Anspach MIA 16 (16cm Minimally Invasive Attachment). These prescription-only attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.
The recall was initiated because the product did not reach the expected sterility assurance level. The recall covers all lots of the affected product.
The products were distributed nationwide to facilities in Florida, Illinois, California, Indiana, Michigan, New Jersey, Texas, Nebraska, North Carolina, Oregon, Pennsylvania, Tennessee, the District of Columbia, Utah, Colorado, Missouri, Kentucky, Maryland, West Virginia, New York, and Minnesota. Healthcare providers and patients should stop using the recalled attachments and contact the manufacturer for further instructions.
The recalled product
- Product
- Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 183
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)
- ALL LOTS
Distribution
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