Hallu®-FIX
NEWDEAL · Model 129732ND · UDI-DI 10381780051978
HXW
Prescription
3
510(k) clearances
320
Adverse events
3
Recalls
223
Facilities
Description
The 1.4mm slot plate left bender is used to shape the HALLU®-C plate according to the bone configuration, together with the plate left bender with reference 129731ND.
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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