Home › Device types › LRZ
Screwdriver, Surgical
FDA product code LRZ · Class 1 · General, Plastic Surgery
225
Registered devices
14
Adverse events
6
Recalls
3
510(k) clearances
Devices with this code
ORTHOMED — ORTHO-MED, INC.ORTHOMED — ORTHO-MED, INC.Bioplate® — Bioplate, Inc.FAICO CMF System — FAICO MEDICAL LLCFAICO CMF System — FAICO MEDICAL LLCBioplate® — Bioplate, Inc.Dental Instrument — Cowellmedi Co.,LtdA.L.P.S. mvX™ — Tyber Medical, LLCBioplate® — Bioplate, Inc.ORTHOMED — ORTHO-MED, INC.Bioplate® — Bioplate, Inc.ORTHOMED — ORTHO-MED, INC.FAICO CMF System — FAICO MEDICAL LLCFAICO CMF System — FAICO MEDICAL LLCFAICO CMF System — FAICO MEDICAL LLCFAICO CMF System — FAICO MEDICAL LLCFAICO CMF System — FAICO MEDICAL LLCTITANEX — VILEX LLCBioplate® — Bioplate, Inc.T-Handle — I.T.S. GmbHDental Instrument — Cowellmedi Co.,LtdORTHOMED — ORTHO-MED, INC.Dental Instrument — Cowellmedi Co.,LtdORTHOMED — ORTHO-MED, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-11-10 | Aesculap, Inc. | The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could |
| 2015-11-10 | Aesculap, Inc. | The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could |
| 2015-11-10 | Aesculap, Inc. | The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could |
| 2015-11-10 | Aesculap, Inc. | The flexible shaft of the instruments may break during orthopedic spinal surgery. There is a risk of a delay in surgery or that a fragment from the shaft could |
| 2015-11-05 | Genesys Orthopedics Systems, LLC | Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off. |
| 2013-02-01 | Integra LifeSciences Corp. | The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery. |
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