Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating
The Anspach Effort, Inc. is recalling specific lots of Otologic Curved Micro Diamond Ball Burrs because they may lack the diamond coating or be the incorrect size.
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, and the defect involves a manufacturing error (missing coating/incorrect size) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 27 units of the Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD. The recall affects Lot Numbers J473111704 and J473111705. These medical devices are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
The recall was initiated because certain lots of the burrs may be missing the diamond coating and the ball may be the incorrect size. The affected devices were distributed in the United States in the states of Kentucky and Texas.
Healthcare providers and facilities that have received these specific lots should stop using the devices and contact the recalling firm for further instructions. Consumers should not use these prescription-only devices.
The recalled product
- Product
- ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 27
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 (3)
- Model/Catalog #:OCM7-15SD
- 1.5 MM Diamond Ball
- Lot Numbers: J473111704 and J473111705
Distribution
Part of a larger recall action
This product is one of 2 recalled by The Anspach Effort, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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