Anspach Recalls Micro Curved Attachments Due to Unclear Directions for Use
The Anspach Effort, Inc. is recalling MCA Micro Curved Attachments and cutting burrs because the directions for use do not clearly specify intended use for delicate bone in otologic procedures.
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: The recall is classified as FDA Class II. The primary issue is a labeling/documentation deficiency (unclear directions for use) rather than a confirmed defect causing injury, which aligns with the 'Moderate' criteria for minor labeling errors or precautionary recalls.
Plain-English summary
The Anspach Effort, Inc. is recalling Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support Sleeves (Cutters and Attachments). The recall involves 6,824 units distributed worldwide, including the United States, Canada, and various international locations.
The recall was initiated after a review of documentation revealed that the current directions for use do not provide clear details regarding the intended use specifically for the MCA burrs. The MCA burrs are intended for use in delicate bone in otologic procedures, such as cochleostomy. The source text notes that the use of the device in dense bone removal may result in complications, though the specific nature of the complications is not fully detailed in the provided excerpt.
Healthcare providers and facilities that have received these devices should stop using them and contact The Anspach Effort, Inc. for instructions on how to return or dispose of the products.
The recalled product
- Product
- Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments) MCA - MICRO CURVED ATTACHMENT, MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM, MCA5-06SD - 0.6MM DIAMOND BALL, 5.6CM, MCA5-07SD - 0.7MM DIAMOND BALL, 5.6CM, MCA5-08SD…
- Manufacturer
- The Anspach Effort, Inc.
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 (20)
- All Lots for MCA - MICRO CURVED ATTACHMENT
- MCA5-05SD - 0.5MM DIAMOND BALL
- 5.6CM
- MCA5-06SD - 0.6MM DIAMOND BALL
- MCA5-07SD - 0.7MM DIAMOND BALL
- MCA5-08SD - 0.8MM DIAMOND BALL
- MCA5-15SB - 1.5MM FLUTED BALL
- MCA5-15SD - 1.5MM DIAMOND BALL
- MCA5-1SB - lMM FLUTED BALL
- MCA5-1SD - lMM DIAMOND BALL
- MCA5-2SB - 2MM FLUTED BALL
- MCA5-2SD - 2MM DIAMOND BALL
- MCA7-05SD - 0.5MM DIAMOND BALL
- 7.3CM
- MCA7-06SD - 0.6MM DIAMOND BALL
- 7 .3CM
- MCA7-07SD - 0.7MM DIAMOND BALL
- MCA7-08SD - 0.8MM DIAMOND BALL
- MCA7-15SB - 1.5MM FLUTED BALL
- MCA7-15SD 1.5MM DIAMOND BALL
Distribution
Distributed nationwide across the United States.
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