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ACRA-CUT
ACRA-CUT INC · Model 14/9mm SDR (SMARTdrill) · UDI-DI 00810607002006
10
510(k) clearances
2,719
Adverse events (2 deaths)
6
Recalls
29
Facilities
Description
Disposable Cranial Perforator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-26 | Integra LifeSciences Corp. (NeuroSciences) | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution. |
| 2025-09-26 | Integra LifeSciences Corp. (NeuroSciences) | Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution. |
| 2025-04-11 | Integra LifeSciences Corp. (NeuroSciences) | Inadequate weld that can potentially cause the product to disassemble. |
| 2025-04-11 | Integra LifeSciences Corp. (NeuroSciences) | Inadequate weld that can potentially cause the product to disassemble. |
| 2020-10-16 | Stryker Instruments Div. of Stryker Corporation | Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use. |
| 2011-07-08 | Biomet Microfixation, Inc. | Biomet Microfixation, Inc., Jacksonville, FL, recalled their IQ Intelligent Device, 72-1000 due to failure of the front bit sensor to detect the correct bit that is installed. When |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.