Home / Recalls / Ormco/Sybronendo / Z-1330-2014

Z-1330-2014 Class II Terminated

Recalled by Ormco/Sybronendo — Glendora, CA

Recall Details

Product Type
Devices
Report Date
April 9, 2014
Initiation Date
March 25, 2014
Termination Date
April 18, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
150 units

Product Description

Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment.

Reason for Recall

Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is misplaced. The misidentification may lead an orthodontist to place the bracket on the wrong tooth, leading to movement 10 degrees in the wrong direction.

Distribution Pattern

Internationally Distributed in the country of Japan.

Code Information

Part Number 494-0110, Lot Number 081351013.

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