Z-1506-2015Class II
M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the...
Specialty Appliances, LLC / initiated 2015-03-09 / Terminated
Specialty Appliance Works, Inc. began a recall of M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient... on . FDA classified it as Class II and gives the reason as "The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1506-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Specialty Appliances, LLC
- Product
- M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relationship and/or occlusion of a patient. the Universal Nut is a component of a Herbst Appliance
- Product code
- ECN Clamp, Wire, Orthodontic
- Reason for recall
- The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
- FDA root cause
- Under Investigation by firm
- Action
- Specialty Applicances sent an Urgent Voluntary Productionn Field Correction Notification dated March 9, 2015, to all affected customers who received the Herbst Appliances and for sales supply orders. The letter advised doctors to monitor the appliance during routine follow-up appointments for signs of corrosion, and for sales supply orders to return affected components to the lab for replacement. Customers were asked to complete and return the enclosed Field Correctivve Action Response Form and return via fax to 678-513-7345. To return affected devices call 800-522-4636 to receive instruction as to how to return it to Speciality Applicances. In the event that customers observe signs of corrosion or a fracture, they should contact customer service at 800-522-4636 or their sales representative. For questions customers should call 800-522-4636 For questions regarding this recall call 678-513-4408, ext 226.
- Quantity in commerce
- 14,428 Universal Nuts
- Distribution
- Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
- Product codes and lots
- Product No. 90885 and 90888
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1502-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1503-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1504-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1505-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1506-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1507-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1508-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1509-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1510-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1511-2015 | Class II | Terminated | Voluntary: Firm initiated |
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