Recall Z-0196-2009 ยท GCJ Laparoscope, General & Plastic Surgery
Stryker Endoscopy
26" Vision Elect HDTV Surgical Viewing Monitor, model number 0240030960, Manufactured by Stryker Endoscopy San Jose Intended to be used as a visualization device for events occurring in the sterile field for endoscopic surgical procedures.
| Date | Oct 24, 2008 (initiated Sep 22, 2008) |
| Status | Terminated |
| Reason | Knob parts stick together, resulting in poor functionality of the knob. |
| Root cause | Device Design |
| Action | Urgent: Device Correction letters dated 9/22/2008 were sent to Sales representatives and all accounts. Sales reps were also notified via email. Each Sales Rep was provided rework instructions, a list of affected accounts and serial numbers, and new knobs to install on affected units. Customers were asked to inspect their inventory for the part number, they were informed that their sales rep would be responsible for replacing the rotary knobs on all affected units, and that they should contact their sales rep to schedule the knob replacement. |
| Quantity | 2265 devices |
| Distribution | Worldwide Distribution --- USA including states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nort |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935234 | STRYKER ENDOSCOPIC VIDEO ACCESSORIES Stryker Endoscopy, Mar 18, 1994 |