Ormco Corporation Titanium Orthos Bracket Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Titanium Orthos Bracket
Brand
Ormco Corporation
Lot Codes / Batch Numbers
Part Number: 448-6111 and lot numbers:04G21, 04G83, 04J29, 04H108, 04K77. Part Number:449-6111 and lot numbers: 04G15, 04J5, 04G14, 04H141, 04H77.
Products Sold
Part Number: 448-6111 and lot numbers:04G21, 04G83, 04J29, 04H108, 04K77. Part Number:449-6111 and lot numbers: 04G15, 04J5, 04G14, 04H141, 04H77.
Ormco Corporation is recalling Titanium Orthos Bracket due to Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.
Recommended Action
Per FDA guidance
Recall letters were mailed from 11/18 thru 11/23. Letters request return of product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026