3M ESPE Unitek Stainless Steel Permanent Molar Crowns , Product Code: 900321, Made in U.S.A by 3M ESPE Dental Products S

FDA device recall Z-0569-2008 · posted 2008-01-24 · Terminated

Recall details

Recalling firm

3M Company / Medical Division

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.

Action taken

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

Status

Terminated

Product code

ELZ

Quantity affected

975

Distribution

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

Date initiated

2007-10-17

Date posted

2008-01-24

Date terminated

2008-10-17

Location

South St Paul, MN