Home › ACRA-CUT INC › Dura Separator, Standard, Reusable
Dura Separator, Standard, Reusable
ACRA-CUT INC · Model 800-713 · UDI-DI 00810607000552
10
510(k) clearances
351
Adverse events
2
Recalls
211
Facilities
Description
Dura Separator, Standard, Reusable 8.0mm #3 (Similar to Penfield#3)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-04-04 | Zimmer Inc. | A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdrive |
| 2010-07-02 | Integra LifeSciences Corp | Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.