Anspach Effort 3mm Diamond Ball Burrs Recalled for Grit Size Defect
The Anspach Effort, Inc. is recalling 1,827 3mm Diamond Ball burrs because three batches may have diamond grit larger than intended.
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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a manufacturing defect regarding grit size without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
The Anspach Effort, Inc. is recalling 1,827 units of the ***REF S-3D*** 3mm Diamond Ball burr. These medical devices are used for cutting and shaping bone. The recall involves specific lot numbers: D433040800, D403040236, and D383039472.
The recall was initiated because three batches of the product may have diamond grit size larger than intended applied to the head of the cutting burr. This defect could affect the performance of the device during surgical procedures.
The affected products were distributed nationwide in the United States, including DC and numerous states, as well as internationally to France, Canada, Great Britain, Mexico, Australia, Sweden, and the Netherlands. Healthcare providers and patients should check their inventory for the specific lot numbers listed and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 1,827
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)
- Lots numbers: D433040800
- D403040236
- D383039472.
Distribution
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