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Z-1502-2015 Class II Terminated

Recalled by Specialty Appliance Works, Inc. — Cumming, GA

FDA device recall Z-1502-2015 was initiated by Specialty Appliance Works, Inc. on March 9, 2015 and is designated Class II. Reason for recall: The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS. The recall status is terminated (terminated January 12, 2017). Affected quantity: 14,428 Universal Nuts.

Recall Details

Product Type: Devices
Report Date: April 29, 2015
Initiation Date: March 9, 2015
Termination Date: January 12, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,428 Universal Nuts

Product Description

Herbst Universal Nut which is used in a Herbst Appliance 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.

Reason for Recall

The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

Distribution Pattern

Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.

Code Information

1405016

Other recalls by Specialty Appliance Works, Inc.

Z-1510-2015 Class II — Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk (March 9, 2015)
Z-1509-2015 Class II — TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component (March 9, 2015)
Z-1503-2015 Class II — MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Ki (March 9, 2015)
Z-1506-2015 Class II — M-4 Mechanism Set 16 mm and M-4 Mechanism Set 19 mm A Herbst Appliance is used (March 9, 2015)
Z-1504-2015 Class II — TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/pk) A Herb (March 9, 2015)
Z-1507-2015 Class II — HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 a (March 9, 2015)
Z-1505-2015 Class II — Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, an (March 9, 2015)
Z-1511-2015 Class II — TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Cro (March 9, 2015)
Z-1508-2015 Class II — LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/pk) (March 9, 2015)