Home › NOVO SURGICAL, INC. › Novo Surgical
Novo Surgical
NOVO SURGICAL, INC. · Model N6860-54 · UDI-DI 00842331119316
GZT
Prescription
10
510(k) clearances
112
Adverse events
6
Recalls
81
Facilities
Description
leyla brain retractors accessories, for mounting retractor to the operating table, ball joint clamp for mounting the rigid holding arm to the side rail of the operating table
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-06-19 | Nico Corp. | Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and expiration date, etc |
| 2012-08-21 | Vycor Medical, Inc. | Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device. |
| 2012-07-17 | Nico Corp. | BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packag |
| 2012-07-17 | Nico Corp. | BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packag |
| 2007-12-19 | Abbott Spine | Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearing |
| 2003-02-26 | Ohio Medical Instrument Co Inc | The component was manufactured with an insufficient weld that could break during use. |
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.