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Recall Observatory FDA recall evidence

Device 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 posterior and anterior teeth.

Z-2100-2013

August 05, 2013

Class II

Product summary

Firm
3M Company/3m Espe Dental Products
Event
Event 65913
Status
Terminated
Classification
Class II
Quantity
3409 crowns (2949 US and 460 OUS)
Official record key
device-enforcement:Z-2100-2013

Official wording

Reason: 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.

Code information: Product Code 902150 (Kit) ¿ Lot codes N492036, N500930 (not distributed) and N495695 Product Code 900114 (Refill) ¿ Lot Codes N486012, N497616 (not distributed) and N483920

Distribution pattern: Worldwide Distribution - USA Nationwide in the states of CA, FL, GA, IN, IA, MO, NV, NJ, NY, PA, SC, TN, TX, WA. and the country of CANADA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these products have been manufactured with the incorrect marginal contour edge.