M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A recall
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…
Why was M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A recalled?
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product No. 90885 and 90888
- 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…
- Recalling firm
- Specialty Appliance Works, Inc.
- Quantity
- 14,428 Universal Nuts
- Distribution
- Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
- Recall date
- April 29, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)