Recall Z-1558-2008 ยท GCJ Laparoscope, General & Plastic Surgery
Stryker Endoscopy
24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope or arthroscope is indicated for use.
| Date | Aug 24, 2008 (initiated Mar 31, 2008) |
| Status | Terminated |
| Reason | The coupler on this device was manufactured without set-screws that are used to hold and center the rear assembly and the endobody. The coupler is part of the camera system and affects the ability to focus. |
| Root cause | Nonconforming Material/Component |
| Action | Only one customer had all of the defective couplers. The firm called this customer on March 27, 2008, and asked that the 28 couplers remaining in their possession be returned. |
| Quantity | 28 units |
| Distribution | Product was delivered to one consignee in Iowa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983566 | 3-CHIP VIDEO CAMERA Stryker Endoscopy, Jan 11, 1999 |