Z-1330-2014Class II

Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013

Name: Z-1330-2014 Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013
Creator: Ormco/Sybronendo
Published: 2014-03-25
License: https://open.fda.gov/license/

Ormco/Sybronendo / initiated 2014-03-25 / Terminated

FDA source

Ormco/Sybronendo began a recall of 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... on 2014-03-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1330-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-25
Posted: 2014-04-04
Terminated: 2014-04-18
Recalling firm: Ormco/Sybronendo
Product: 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 code: DYW Bracket, Plastic, Orthodontic
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.
FDA root cause: Use error
Action: Ormco Corporation initiated this recall by sending recall letters to customers on March 25, 2014 via 1st class mail. The letter identified the affected product, problem and actions to be taken. The consignees are instructed to complete the "Return Form" and return any affected product in their inventory. The letter was written in Japanese language and accompanied by a "Return Form".
Quantity in commerce: 150 units
Distribution: Internationally Distributed in the country of Japan.
Product codes and lots: Part Number 494-0110, Lot Number 081351013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1330-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1330-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-09	2014-04-03

Product code DYW

K943245Class IISpirit MbSybron Dental Specialties, Inc. / cleared 1994-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)