Home › Medos International Sàrl › MOUNTAINEER
MOUNTAINEER
Medos International Sàrl · Model 288313000 · UDI-DI 10705034221823
HXW
Prescription
3
510(k) clearances
320
Adverse events
3
Recalls
224
Facilities
Description
MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL PLATE BENDER
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-06-30 | Aesculap Implant Systems LLC | Customized coronal rod benders may deform the implant when used with the spinal system devices. |
| 2021-06-30 | Aesculap Implant Systems LLC | Customized coronal rod benders may deform the implant when used with the spinal system devices. |
| 2014-12-15 | Synthes, Inc. | Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while altern |
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.