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Ambler Surgical
AMBLER SURGICAL CORP. · Model Smith ramus separator · UDI-DI 00190660197353
HAO
Prescription
10
510(k) clearances
351
Adverse events
2
Recalls
212
Facilities
Description
Smith ramus separator, 9'', straight 12.0mm blades, spring handle
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. |
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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.