—#69537

Product

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.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K983566
Affected lot / code info: Model Number: 1088-020-121S2 Lot Numbers: Shipped: 07L046134, 07L046144, 07L046154, 07L046164, 07L046184, 07L046194, 07L046214, 07L046224, 07L046234, 07L046244, 07L046254, 07L046274, 07L046284, 07L046294, 07L046304, 07L046324, 07L046334, 07L046344, 07L046364, 07L046374, 07L046384, 07L046394, 07L046404, 07L046414, 07L046424, 07L046454, 07L046464, and 07L046474.

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138

Distribution

Distribution pattern: Product was delivered to one consignee in Iowa.

Timeline

Recall initiated: 2008-03-31
Posted by FDA: 2008-08-24
Terminated: 2008-09-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #69537. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.