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Terminated

3M ESPE Unitek Stainless Steel Permanent Molar Crowns , Product Code: 900321, Made in U.S.A by 3M ESPE Dental Products St. Paul, MN 55144-1000.

FDA Recall Z-0569-2008 · Posted 2008-01-24

Recalling Firm3M Company / Medical Division
Recall StatusTerminated
Product CodeELZ
Date Initiated2007-10-17
Date Terminated2008-10-17
Product Quantity975

Reason for Recall

Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns.

Firm Action

3M ESPE Dental Products initially contacted Distributors and Doctors on 10/22/07 through telephone calls, and sent a Device Recall letter via Fed Ex - Overnight on 10/22/07. The letter informed the users that Unitek Stainless Steel Permanent Crowns Lot # P060928, Product Code 900321 may be mislabeled as Unitek Stainless Steel Primary Molar Crowns. Users were asked to stop using and/or distributing the product and contact ESPE Dental Products at 1-800-237-1650 to initiate product return and replacement.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution USA including states of TX, IN, FL, NV, KY, TN, MN, WA, NJ, PA, IL, CA, and IA, and country of CANADA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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