24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, naso
FDA device recall Z-1558-2008 · posted 2008-08-24 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- 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 taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 28 units
- Distribution
- Product was delivered to one consignee in Iowa.
- Date initiated
- 2008-03-31
- Date posted
- 2008-08-24
- Date terminated
- 2008-09-17
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3-CHIP VIDEO CAMERA (K983566) | Stryker Endoscopy | 1999-01-11 |