Home / Recalls / Specialty Appliance Works, Inc. / Z-1511-2015

Z-1511-2015 Class II Terminated

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

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

TS ROC Crown Component 4UR (5/pk), TS ROC Crown Component 5UR (5/pk), TS ROC Crown Component 6UR (5/pk), TS ROC Crown Component 7UR (5/pk), TS ROC Crown Component 8UR (5/pk), TS ROC Crown Component 4LR (5/pk), TS ROC Crown Component 5LR (5/pk), TS ROC Crown Component 6LR (5/pk), TS ROC Crown Component 7LR (5/pk), TS ROC Crown Component 8LR (5/pk), TS ROC Crown Component 4UL (5/pk), TS ROC Crown Component 5UL (5/pk), TS ROC Crown Component 6UL (5/pk), TS ROC Crown Component 7UL (5/pk), TS ROC Crown Component 8UL (5/pk), TS ROC Crown Component 4LL (5/pk), TS ROC Crown Component 5LL (5/pk), TS ROC Crown Component 6LL (5/pk), TS ROC Crown Component 7LL (5/pk), TS ROC Crown Component 8LL (5/pk) 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

Product No. 91720, 91721, 91722, 91723, 91724, 91725, 91726, 91727, 91728, 91729, 91730, 91731, 91732, 91733, 91734, 91735, 91736, 91737, 91738, and 91739

Other recalls by Specialty Appliance Works, Inc.

  • Z-1502-2015 Class II — Herbst Universal Nut which is used in a Herbst Appliance A Herbst Appliance is (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-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-1507-2015 Class II — HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 a (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-1505-2015 Class II — Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, an (March 9, 2015)
  • Z-1510-2015 Class II — Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/pk (March 9, 2015)
  • Z-1508-2015 Class II — LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (5/pk) (March 9, 2015)