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Terminated

Titanium Orthos Bracket

FDA Recall Z-0309-05 · Posted 2004-12-15

Recalling FirmOrmco Corporation
Recall StatusTerminated
Product CodeEJF
Date Initiated2004-11-18
Date Terminated2005-06-17
Product Quantity6,257

Reason for Recall

Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.

Firm Action

Recall letters were mailed from 11/18 thru 11/23. Letters request return of product.

Root Cause

Other

Distribution Pattern

Nationwide and France, Luxembourg, Spain, Netherlands, Russia, Ireland, Italy, Germany, United Kingdom, Hungary, Finland, Denmark.

Official Source

View FDA Recall →

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

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