FDA Device recall Z-1509-2015
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 Compon…
- FDA Device
- Class II
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class II recall of 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 Compon… by Specialty Appliance Works, citing the Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1509-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-09 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Specialty Appliance Works |
| Distribution | US |
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), 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
Reason
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
Identifiers
| code_info | Product No. 91672, 91673, 91674, 91677, 91678, 91679, 91682, 91683, 91687, 91688, and 91689 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1509-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.