CLASS II Device recall · Reported 29 Apr 2015 · FDA Enforcement Report
TS ROC Crown Component 4UR, TS ROC Crown Component 5UR recalled
Specialty Appliance Works is recalling TS ROC Crown Component 4UR, TS ROC Crown Component 5UR, TS ROC Crown Component 6UR, TS, distributed nationwide in the US. The recall was initiated on 9 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1511-2015
- FDA event ID
- 70787
- Recalling firm
- Specialty Appliance Works, Cumming, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Mar 2015
- FDA classified
- 22 Apr 2015
- Reported
- 29 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 9 Mar 2015 | Recall initiated by company | |
| 22 Apr 2015 | Classified by FDA | +44 days |
| 29 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
Questions about this recall
Is TS ROC Crown Component 4UR, TS ROC Crown Component 5UR, TS ROC Crown Component 6UR, TS recalled?
Yes. Specialty Appliance Works recalled TS ROC Crown Component 4UR, TS ROC Crown Component 5UR, TS ROC Crown Component 6UR, TS on 9 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1511-2015.
Why was it recalled?
The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
Which lots are affected?
Product No. 91720, 91721, 91722, 91723, 91724, 91725, 91726, 91727, 91728, 91729, 91730, 91731, 91732, 91733, 91734, 91735, 91736, 91737, 91738, and 91739
Where was it sold?
Worldwide Distribution - US nationwide including Puerto Rico, Brazil, China, Colombia, Germany, Ireland, Mexico, Switzerland, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Specialty Appliance Works
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TS Crown Component 4UR, TS Crown Component 5UR recalled | Specialty Appliance Works | Other | Nationwide |
| Device | CLASS II | Upper Right Telescope Unibodies recalled by Specialty Appliance Works | Specialty Appliance Works | Other | Nationwide |
| Device | CLASS II | Herbst Universal Nut which is used recalled by Specialty Appliance Works | Specialty Appliance Works | Other | Nationwide |
| Device | CLASS II | LR Telescoping Cantilever Arms recalled by Specialty Appliance Works | Specialty Appliance Works | Other | Nationwide |
| Device | CLASS II | HTM Mechanism Set Set 16, HTH Mechanism Set Size recalled | Specialty Appliance Works | Other | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |