Anspach Twist Drill Recall Due to Incorrect Length Labeling
The Anspach Effort, Inc. is recalling 29 single-use sterile twist drills 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 error regarding the physical dimensions of the device. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving minor labeling or specification errors.
Plain-English summary
The Anspach Effort, Inc. is recalling 29 units of the Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. These are single-use sterile bone cutting burs intended for prescription use only.
The recall was initiated because the cutter was longer than was stated on the label. The affected products are identified by Lot #s D323038131 and D343038845.
The products were 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. Users should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 29
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 (1)
- Lot #'s: D323038131 and D343038845
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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