Anspach Effort Recalls Rotating Large Craniotomes Due to Missing Service Interval
The Anspach Effort, Inc. is recalling eight Rotating Large Craniotomes because the supplied directions for use did not include a recommended service interval.
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, but the specific defect is a documentation error (missing service interval) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
The Anspach Effort, Inc. is recalling eight units of the Rotating Large Craniotome (Part No. CRANI-L-R). The recall was initiated because the supplied Directions for Use (DFU) did not contain a recommended service interval.
The affected units are identified by DFU 18-0048 and include all serial numbers shipped to customers prior to September 27, 2016. The products were distributed worldwide, including nationwide in the United States (specifically Hawaii and the District of Columbia), Puerto Rico, Guam, and Japan.
Consumers and healthcare facilities should stop using the affected devices and contact The Anspach Effort, Inc. for further instructions regarding the missing service interval information.
The recalled product
- Product
- Rotating Large Craniotome
- Manufacturer
- The Anspach Effort, Inc.
- Hazard
- Affected units
- 8
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 (3)
- All serial numbers shipped to customers prior to 09/27/2016
- DFU 18-0048
- Part No. CRANI-L-R.
Distribution
Part of a larger recall action
This product is one of 103 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.
See all 103 products in this recall →Related recalls
Same manufacturer · The Anspach Effort, Inc.
See all →- HighAdult Craniotome Bearings May Detach During Surgical Use
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Separate During Surgery
FDA (Devices) · 2023-01-18
- HighLarge Craniotome Attachment Ball Bearings Risk Loosening During Surgery
FDA (Devices) · 2023-01-18
- HighAnspach Adult Rotating Craniotome Attachment ball bearings may detach during surgery
FDA (Devices) · 2023-01-18
- HighCraniotome Attachment Ball Bearings May Detach During Surgery
FDA (Devices) · 2023-01-18
Same hazard · documentation error
See all →- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- LowMindray cPM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- LowMindray Recalls Passport Series Patient Monitor Operator's Manuals
FDA (Devices) · 2026-10-14
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateHenry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
FDA (Devices) · 2026-09-02
Similar recalls
- HighAdult Craniotome Bearings May Detach During Surgical Use
FDA (Devices) · 2023-01-18
- HighSurgical Craniotome Attachment Ball Bearings Have Detached During Surgery
FDA (Devices) · 2023-01-18
- HighLarge Craniotome Attachment Ball Bearings Risk Loosening During Surgery
FDA (Devices) · 2023-01-18
- HighPediatric Craniotome Recalled for Ball Bearing Detachment Risk
FDA (Devices) · 2023-01-18
- HighAdult Craniotome Attachment Recalled for Ball Bearing Failure Risk
FDA (Devices) · 2023-01-18
- ModerateAnspach Custom Circular ePLUS-FP Medical Device Recall for Quality System Non-Compliance
FDA (Devices) · 2014-07-02