Anspach Bone Cutting Burs Recalled for Potential Sterile Barrier Breach
The Anspach Effort, Inc. is recalling single-use sterile bone cutting burs and irrigation clips due to observed layer separation that may compromise the sterile barrier.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential breach in the sterile barrier, which poses a risk of infection, but the source text does not report any actual illnesses, injuries, or hospitalizations. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Anspach Effort, Inc. is recalling 1,805,022 single-use sterile bone cutting burs and 55,026 irrigation clips. The recall was initiated after the manufacturer observed separation between clear layers of the pouch during real-time aging studies. This separation creates a possibility of a breach in the sterile barrier.
The affected products are prescription-only medical devices distributed worldwide, including in the United States and numerous international markets. The source text does not specify particular lot numbers or expiration dates, but indicates a broad distribution pattern.
Healthcare providers and patients should stop using the affected products and contact The Anspach Effort, Inc. for further instructions or replacement. The recall is classified as Class II by the FDA, indicating a situation where use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
- Manufacturer
- The Anspach Effort, Inc.
Distribution
Distributed nationwide across the United States.
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