Ormco/Sybronendo: Medical Device Recall in 2014 - (Recall #: Z-1330-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 25, 2014

Date Posted: April 9, 2014

Recall Number: Z-1330-2014

Event ID: 67849

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.

Status: Terminated

Product Quantity: 150 units

Code Information:

Part Number 494-0110, Lot Number 081351013.

Distribution Pattern:

Internationally Distributed in the country of Japan.

Voluntary or Mandated:

Voluntary: Firm initiated