Anspach Otologic Diamond Ball Burrs Recalled for Missing Coating
The Anspach Effort, Inc. is recalling 27 Otologic Curved Micro Diamond Ball Burrs because they may be missing the diamond coating or be the incorrect size.
What this means for you
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 (missing coating/incorrect size) represents a functional failure of a surgical instrument without reported injuries or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The Anspach Effort, Inc. is recalling 27 units of the Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD. 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 these burrs may be missing the diamond coating and the ball may be the incorrect size. The affected lot number is J473111699. The devices were distributed in the United States in the states of Kentucky and Texas.
Healthcare providers and patients should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD 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 #: OCM7-2SD
- 2.0 MM Diamond Ball
- Lot Numbers: J473111699.
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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