Stryker Brand 5.5mm 6 Flute Barrel Bur, Model Number: 375-951-000; Product is distributed by Stryker Endoscopy, 5900 Opt
FDA device recall Z-0786-05 · posted 2005-05-03 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- The device has the potential to overheat and cause patient burns during use.
- Action taken
- 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
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 28935 boxes, 5 units per box.
- Distribution
- 740 domestic consignees
- Date initiated
- 2005-02-08
- Date posted
- 2005-05-03
- Date terminated
- 2005-05-20
- Location
- San Jose, CA
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