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DIPLOMAT
SIGNUS Medizintechnik GmbH · Model Bending iron, in-situ · UDI-DI 04047844043585
HXW
Prescription
3
510(k) clearances
304
Adverse events
3
Recalls
223
Facilities
Description
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
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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