Z-1558-2008

24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general...

Name: Z-1558-2008 24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general...
Creator: Stryker Endoscopy
Published: 2008-03-31
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2008-03-31 / Terminated / root cause: manufacturing process

FDA source

Stryker Endoscopy began a recall of 24mm Rotating C-Mount Coupler, Model Number 1088-020-121S2. The device in indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy... on 2008-03-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1558-2008
Status: Terminated
Initiated: 2008-03-31
Posted: 2008-08-24
Terminated: 2008-09-17
Recalling firm: Stryker Corp.
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 28 units
Distribution: Product was delivered to one consignee in Iowa.
Product codes and lots: 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.

Product code GCJ

K983566Class II3-Chip Video CameraStryker Endoscopy / cleared 1999-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)