FDA Device

Titanium Orthos Bracket

Hazard

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

What You Should Do

Remedy

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

Products

Titanium Orthos Bracket
Brand
Ormco Corporation
UPC
Part Number: 448-6111 and lot numbers:04G21, 04G83, 04J29, 04H108, 04K77. Part Number:449-6111 and lot numbers: 04G15, 04J5, 04G14, 04H141, 04H77.

Units Affected

6,257