FDA Recall
Terminated
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.
Recall: Z-1558-2008
·
Initiated March 31, 2008
Recall
- Recall Number
- Z-1558-2008
- Event Number
- 47463
- Firm
- Stryker Endoscopy
- FEI Number
- 2936485
- Product Code
- GCJ
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- March 31, 2008
- Posted
- August 24, 2008
- Terminated
- September 17, 2008
- Address
- 5900 Optical Ct, San Jose, CA, 95138
Description
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.
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.
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.
Distribution
Product was delivered to one consignee in Iowa.
Quantity
28 units