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SUMMIT
DEPUY SPINE, LLC · Model 274664000 · UDI-DI 10705034193281
HXW
Prescription
3
510(k) clearances
320
Adverse events
3
Recalls
224
Facilities
Description
SUMMIT SI OCT SPINAL FIXATION SYSTEM ROD BENDER (FRENCH) 3.0 / 4.0mm
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 |
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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.