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Terminated

Stryker Visum 300 Ceiling-mounted Exam Light.

FDA Recall Z-1992-2013 · Posted 2013-08-21

Recalling FirmStryker Communications
Recall StatusTerminated
Product CodeKZF
Date Initiated2013-07-25
Date Terminated2015-04-03
Product Quantity1,375 units

Reason for Recall

Potential incomplete final weld on the drop tube flange.

Firm Action

The firm decided to recall and notified consignees with an "Urgent Medical Device Correction/Removal" notification letter dated 07/29/13. The product issue was described and recommended actions were provided. Customers may contact Stryker Technical Support at 866-841-5663.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution: US natiowide and to the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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