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General Instrument
ALPHATEC SPINE, INC. · Model CI-10962-R · UDI-DI 00840180508343
HXW
Prescription
3
510(k) clearances
320
Adverse events
3
Recalls
223
Facilities
Description
In-Situ Sagittal Bender, Right, 6.0 MM
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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