Exact FDA event identifier

Event 70787

10 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 09, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Specialty Appliance Works, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

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.

Z-1502-2015

Recall number: Z-1502-2015
Initiated: March 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Specialty Appliance Works, Inc.
Quantity: 14,428 Universal Nuts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

1405016

Distribution pattern

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

device · product 2 of 10

MiniScope Hst ROC Crown 15 Patient Kit, and MiniScope Herbst Crown 15 Patient Kit 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.

Z-1503-2015

Recall number: Z-1503-2015
Initiated: March 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Specialty Appliance Works, Inc.
Quantity: 14,428 Universal Nuts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product No. 90127 and 90139

Distribution pattern

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

device · product 3 of 10

TS Herbst Nuts with Backing (10/pk) and TS Herbst Nuts Universal (10/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.

Z-1504-2015

Recall number: Z-1504-2015
Initiated: March 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Specialty Appliance Works, Inc.
Quantity: 14,428 Universal Nuts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product No. 90869 and 90875

Distribution pattern

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

device · product 4 of 10

Specialty MiniScope Mech. Set Size 18, Specialty MiniScope Mech. Set Size 21, and Specialty MiniScope Mech. Set Size 24 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.

Z-1505-2015

Recall number: Z-1505-2015
Initiated: March 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Specialty Appliance Works, Inc.
Quantity: 14,428 Universal Nuts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product No. 90870, 90876 and 90879

Distribution pattern

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

device · product 5 of 10

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

Z-1506-2015

Recall number: Z-1506-2015
Initiated: March 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Specialty Appliance Works, Inc.
Quantity: 14,428 Universal Nuts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product No. 90885 and 90888

Distribution pattern

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

device · product 6 of 10

HTM Mechanism Set Set 16, HTH Mechanism Set Size 18, HTH Mechanism Set Size 21 and HTH Mechanism Set Size 24 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.

Z-1507-2015

Recall number: Z-1507-2015
Initiated: March 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Specialty Appliance Works, Inc.
Quantity: 14,428 Universal Nuts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product No. 90900, 90904, 90907, and 90910

Distribution pattern

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

device · product 7 of 10

LR Telescoping Cantilever Arms (5/pk) and LL Telescoping Cantilever Arms (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.

Z-1508-2015

Recall number: Z-1508-2015
Initiated: March 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Specialty Appliance Works, Inc.
Quantity: 14,428 Universal Nuts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product No. 91522 and 91523

Distribution pattern

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

device · product 8 of 10

TS Crown Component 4UR (5/pk), TS Crown Component 5UR (5/pk), TS Crown Component 6UR (5/pk), TS Crown Component 4LR (5/pk), TS Crown Component 5LR (5/pk), TS Crown Component 6LR (5/pk), TS Crown Component 4UL (5/pk), TS Crown Component 5UL (5/pk), TS Crown Component 4LL (5/pk), TS Crown Component 5LL (5/pk), and TS Crown Component 6LL (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

Z-1509-2015

Recall number: Z-1509-2015
Initiated: March 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Specialty Appliance Works, Inc.
Quantity: 14,428 Universal Nuts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product No. 91672, 91673, 91674, 91677, 91678, 91679, 91682, 91683, 91687, 91688, and 91689

Distribution pattern

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

device · product 9 of 10

Upper Right Telescope Unibodies (5/pk) and Upper Left Telescope Unibodies (54/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.

Z-1510-2015

Recall number: Z-1510-2015
Initiated: March 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Specialty Appliance Works, Inc.
Quantity: 14,428 Universal Nuts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Product No. 91695 and 91696

Distribution pattern

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

device · product 10 of 10

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.

Z-1511-2015

Recall number: Z-1511-2015
Initiated: March 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Specialty Appliance Works, Inc.
Quantity: 14,428 Universal Nuts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

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