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Terminated

Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment.

FDA Recall Z-1321-2014 · Posted 2014-04-02

Recalling FirmOrmco/Sybronendo
Recall StatusTerminated
Product CodeEJF
Date Initiated2014-03-25
Date Terminated2014-10-27
Product Quantity150 units

Reason for Recall

Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets.

Firm Action

Recall notification letters sent to all affected consignees via 1st class mail on March 24, 2014. The consignees are instructed to complete the Return Form and have the option to return any affected product in their inventory to Ormco Corporation. The letter is dated "March 24, 2014" and titled: "URGENT: MEDICAL DEVICE RECALL". The letter informed customers of the recall, reason for recall, product description with part number and lot number, instructions to follow, and contact information. The letter was accompanied by a "Recall Return/Acknowledgement Form".

Root Cause

Other

Distribution Pattern

US and Canada.

Official Source

View FDA Recall →

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

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