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P-K Titanium Motility Peg System
INTEGRATED ORBITAL IMPLANTS INC · Model I00057 · UDI-DI 00854066006236
LRZ
Prescription
3
510(k) clearances
14
Adverse events
6
Recalls
28
Facilities
Description
Titanium Threaded Sleeve Driver (Wrench) used with IOI's Titanium Threaded Sleeve/Flat Peg (I00045) and Titanium Large Threaded Sleeve/Flat Peg (I00100). Manual, single-use, nonsterile surgical instrument.
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 be left in a patien |
| 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 be left in a patien |
| 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 be left in a patien |
| 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 be left in a patien |
| 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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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.