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Specialty Appliance Works Recalls
10 recalls on record · April 29, 2015 to April 29, 2015 · Medical Devices
April 29, 2015Medical DevicesFDA
Specialty Appliance Works, Inc. recalls TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Co
Hazard: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
April 29, 2015Medical DevicesFDA
Specialty Appliance Works, Inc. recalls Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk) A Herbst Appliance is used to affect
Hazard: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
April 29, 2015Medical DevicesFDA
Specialty Appliance Works, Inc. recalls TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/p
Hazard: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
April 29, 2015Medical DevicesFDA
Specialty Appliance Works, Inc. recalls LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/pk) A Herbst Appliance is used to affect ch
Hazard: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
April 29, 2015Medical DevicesFDA
Specialty Appliance Works, Inc. recalls HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 A Herbst A
Hazard: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
April 29, 2015Medical DevicesFDA
Specialty Appliance Works, Inc. recalls M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used to affect changes in the skeletal relati
Hazard: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
April 29, 2015Medical DevicesFDA
Specialty Appliance Works, Inc. recalls Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24
Hazard: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
April 29, 2015Medical DevicesFDA
Specialty Appliance Works, Inc. recalls TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herbst Appliance is used to affect changes i
Hazard: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
April 29, 2015Medical DevicesFDA
Specialty Appliance Works, Inc. recalls MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit A Herbst Appliance is used to affect
Hazard: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
April 29, 2015Medical DevicesFDA
Specialty Appliance Works, Inc. recalls Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is used to affect changes in the skeletal r
Hazard: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.