Anspach Effort Recalls Sterile Bone Cutting Burrs Due to Breakage Risk
The Anspach Effort, Inc. is recalling specific sterile bone cutting burrs because the cutter may come apart during use.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a surgical instrument breaking during a procedure on the spine or cranium, which poses a significant risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
The Anspach Effort, Inc. is recalling single-use sterile bone cutting burrs used with XMax, microMax, microMax Plus, eMax, eMax2, and eMax2 Plus High Speed Drill Systems. The recall is due to a defect where the cutter is possible to come apart.
The affected products are 4.8 mm x 2mm Twist Drills with Depth Stops, intended for use with the SHORT-HD Attachment. The specific lot numbers involved are E203050779 and E383055709. The distribution pattern includes US Nationwide Distribution, specifically noting Arizona and California.
Healthcare providers and patients should stop using these devices immediately. The Anspach Effort, Inc. is the recalling firm responsible for this action.
The recalled product
- Product
- .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 5
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 numbers E203050779 and E383055709.
Distribution
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