Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic br
FDA device recall Z-1330-2014 · posted 2014-04-04 · Terminated
Recall details
- Recalling firm
- Ormco/Sybronendo
- 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.
- Action taken
- 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".
- Root cause
- Use error
- Status
- Terminated
- Product code
- DYW
- Quantity affected
- 150 units
- Distribution
- Internationally Distributed in the country of Japan.
- Date initiated
- 2014-03-25
- Date posted
- 2014-04-04
- Date terminated
- 2014-04-18
- Location
- Glendora, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPIRIT MB (K943245) | Sybron Dental Specialties, Inc. | 1994-08-23 |