Anspach Effort Recalls Bearing Sleeve Devices Due to Metal Fragment Risk
The Anspach Effort, Inc. is recalling 8 MA-15C Bearing Sleeve devices distributed in Massachusetts. The recall addresses a risk of metal fragments remaining in the surgical site.
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 risk-of-harm product (retained metal fragments in a surgical site) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
The Anspach Effort, Inc. is recalling 8 units of the 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. These reusable devices are used with dissection tools for transphenoidal and skull base procedures. The affected units were distributed in the state of Massachusetts and are identified by lot number 2000930.
The recall was initiated because contact between the bur and the bur guard could generate metal fragments. These fragments may or may not be visible to the surgeon and can potentially remain in the surgical site. Additionally, the materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue, and inspection results for the bur guards were not documented.
This is a Class II recall. The source text does not specify specific actions for consumers or patients, but the devices are subject to recall due to the potential for retained metal fragments.
The recalled product
- Product
- Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 8
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)
- Lot number: 2000930
Distribution
Distributed in 1 state:
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