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3M™ Unitek™

3M UNITEK CORPORATION · Model 536-620 · UDI-DI 00652221099082

ECN Prescription
0
510(k) clearances
4
Adverse events
10
Recalls
105
Facilities

Description

536-620 Unitek™ Archwire Hook Round .022 Split Crimpable 10/Pk

Recalls

DateFirmReason
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.
2015-03-09Specialty Appliance Works, Inc.The Universal Nut, a component of the orthodontic Herbst Appliance was made with 416 SS and not the specified 303 SS.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.