3M ESPE Stainless Steel Primary Molar Crowns, Made in USA by 3M ESPE Dental Products, St Paul, MN. Unitek" Primary Stain

FDA device recall Z-0463-2011 · posted 2010-11-26 · Terminated

Recall details

Recalling firm

3M Company / Medical Division

Reason for recall

Unitek Stainless Steel Permanent Crowns with product Codes 902150, 900213, and 900223, is mislabeled. The crown contained within the package is incorrectly labeled; series UL3 crowns are labeled series UR3 and vice versa. The lid of the package correctly identified the product number and lot. This mislabeling could result in placement on the right side of a crown intended for use on the left, and

Action taken

3M ESPE issued a Device Recall letter dated October 6, 2010 to distributors and dentists. The letter listed the product being recalled including code and lot codes, background information including a picture of the product problem, and the recall procedure. The letter included a template letter to be used by distributors to inform their customers who have received the product. Mislabeled product is to be quarantined and returned to 3M ESPE. 3M ESPE can be contacted at 651 733-1110.

Root cause

Packaging process control

Status

Terminated

Product code

ELZ

Quantity affected

9819

Distribution

Nationwide Distribution: Throughout USA, including the states of AZ, CA, GA, IL, IN, IA, LA, MA, MN, MO, NV,NJ, NY, NC, PA, TN, TX, WA, and WI. Canada and Dominican Republic

Date initiated

2010-10-06

Date posted

2010-11-26

Date terminated

2012-02-04

Location

Saint Paul, MN