Anspach Recalls Single-Use Sterile Bone Cutting Burs Due to Length Discrepancy
The Anspach Effort, Inc. is recalling 599 single-use sterile bone cutting burs because the cutters were longer than stated on the label.
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 hazard is a labeling discrepancy regarding the physical dimensions of the device. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity rating.
Plain-English summary
The Anspach Effort, Inc. is recalling 599 single-use sterile bone cutting burs, specifically the S-1504TD Twist Drill for 1.5mm x 4mm screw. The recall was initiated because the cutters were longer than the length stated on the product label.
The affected products are prescription-only medical devices distributed worldwide, including in the United States (California, Colorado, Indiana, Kentucky, Maryland, and Texas) and internationally to Japan, Taiwan, the United Kingdom, Sweden, and Germany. The specific lot numbers involved in this recall are D293037349, D323038110, and D363039140.
Healthcare providers and patients should stop using these specific bone cutting burs and contact The Anspach Effort, Inc. for further instructions or a replacement.
The recalled product
- Product
- AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 599
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 (2)
- Lot #'s: D293037349
- D323038110 and D363039140
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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