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 Recall Z-1558-2008 · Posted 2008-08-24
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Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeGCJ
Date Initiated2008-03-31
Date Terminated2008-09-17
Product Quantity28 units
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Product was delivered to one consignee in Iowa.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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