Device recall

Z-2100-2013: 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code…

FDA device recall · Class II · 3M Company/3m Espe Dental Products

Key facts

Recall number (Z-number) Z-2100-2013
Recall event 65913
Product 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric…
Product code ELZ
Recalling firm 3M Company/3m Espe Dental Products
Recall class Class II
Status Terminated
Termination date Dec 11, 2013
FEI number 3005174370

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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