FDA (Devices) recall action 70787

Specialty Appliance Works, Inc. recalled 10 products on 2015-04-29

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2015-04-29
Critical: 0
Units: 144,280

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–10 of 10

ModerateFDA (Devices)··2015-04-29
Specialty Appliance Works Recalls Universal Nuts for Incorrect Material Composition
Specialty Appliance Works is recalling Universal Nuts used in orthodontic Herbst Appliances because they were manufactured with 416 stainless steel instead of the specified 303 stainless steel.
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 patient. the Universal Nut is a component of a Herbst Appliance
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-29
Specialty Appliance Works Recalls MiniScope Mechanical Set Universal Nuts
Specialty Appliance Works is recalling Universal Nuts for MiniScope Mechanical Sets because they were made with 416 stainless steel instead of the specified 303 stainless steel.
Product
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
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-29
Specialty Appliance Works Recalls Orthodontic Universal Nut Components
Specialty Appliance Works is recalling TS ROC Crown Components because the Universal Nut was made with 416 SS instead of the specified 303 SS.
Product
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),
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-29
Specialty Appliance Works Recalls Orthodontic Universal Nut Components
Specialty Appliance Works is recalling Universal Nut components for Herbst Appliances because they were made with 416 SS instead of the specified 303 SS.
Product
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), T
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-29
Herbst Universal Nut Recalled for Incorrect Stainless Steel Material
Specialty Appliance Works is recalling Herbst Universal Nuts because they were manufactured with 416 SS instead of the specified 303 SS.
Product
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.
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-29
Specialty Appliance Works Recalls Universal Nuts for Incorrect Stainless Steel Material
Specialty Appliance Works is recalling Universal Nuts used in Herbst Appliances because they were made with 416 SS instead of the specified 303 SS.
Product
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.
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-29
Specialty Appliance Works Recalls Universal Nuts for Orthodontic Appliances
Specialty Appliance Works is recalling Universal Nuts for orthodontic Herbst Appliances because they were made with 416 stainless steel instead of the specified 303 stainless steel.
Product
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.
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-29
Specialty Appliance Works Recalls Orthodontic Universal Nuts Due to Material Error
Specialty Appliance Works is recalling 14,428 Universal Nuts used in orthodontic Herbst Appliances because they were manufactured with 416 SS instead of the specified 303 SS.
Product
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.
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-29
Specialty Appliance Works Recalls Universal Nuts for Herbst Appliances
Specialty Appliance Works is recalling Universal Nuts used in Herbst orthodontic appliances because they were made with 416 stainless steel instead of the specified 303 stainless steel.
Product
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.
Category
Distribution
1 state
ModerateFDA (Devices)··2015-04-29
Specialty Appliance Works Recalls Orthodontic Herbst Appliance Nuts
Specialty Appliance Works is recalling TS Herbst Nuts because they were manufactured with 416 stainless steel instead of the specified 303 stainless steel.
Product
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.
Category
Distribution
1 state