Titanium Orthos Bracket
FDA device recall Z-0309-05 · posted 2004-12-15 · Terminated
Recall details
- Recalling firm
- Ormco Corporation
- Reason for recall
- Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.
- Action taken
- Recall letters were mailed from 11/18 thru 11/23. Letters request return of product.
- Root cause
- Other
- Status
- Terminated
- Product code
- EJF
- Quantity affected
- 6,257
- Distribution
- Nationwide and France, Luxembourg, Spain, Netherlands, Russia, Ireland, Italy, Germany, United Kingdom, Hungary, Finland, Denmark.
- Date initiated
- 2004-11-18
- Date posted
- 2004-12-15
- Date terminated
- 2005-06-17
- Location
- Glendora, CA
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