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Terminated

Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker Endoscopy, 5900 Optical Court, San Jose, CA 95138

FDA Recall Z-0786-05 · Posted 2005-05-03

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHRX
Date Initiated2005-02-08
Date Terminated2005-05-20
Product Quantity28935 boxes, 5 units per box.

Reason for Recall

The device has the potential to overheat and cause patient burns during use.

Firm Action

All consignees will be immediately notified via phone calls and a mailed Urgent Product Recall Notice (2 recipients per consignee, Risk Manager and OR Supervisor)

Root Cause

Process control

Distribution Pattern

740 domestic consignees

Official Source

View FDA Recall →

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

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