Anspach Pneumatic and Electric Motor Systems Recalled for Sterility Assurance Failures
The Anspach Effort, Inc. is recalling 115,988 pneumatic and electric motor systems because certain attachments failed to meet sterility assurance levels during sterilization.
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, and the hazard involves a failure to meet sterility assurance levels for a surgical device, which poses a risk of harm (infection) even though specific injury reports are not detailed in the source text.
Plain-English summary
The Anspach Effort, Inc. is recalling 115,988 units of Anspach Pneumatic and Electric Motor Systems. These devices are intended for cutting and shaping bone, including the spine and cranium. The recall covers specific revisions of the devices and their operating manuals, as detailed in the recall codes.
The recall was initiated because several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized using the method specified in the current Directions for Use (DFU). This failure means the devices may not be adequately sterilized, posing a potential risk of infection to patients.
The affected products were distributed worldwide, including in the United States, its territories, and numerous international countries. Healthcare providers and facilities that have these devices should stop using them and contact The Anspach Effort, Inc. for further instructions on how to proceed.
The recalled product
- Product
- Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
- Manufacturer
- The Anspach Effort, Inc.
- Affected units
- 115,988
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 (5)
- DFU: 18-0047: Revisions A & B 18-0074: Revision A
- and 18-0105: Revisions A. Operating Manuals: 19-0010: Revisions A
- and 19-0013: Revisions A
- B
- & C.
Distribution
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