RecallDepth

INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.

Company
Ace Surgical Supply Co., Inc.
Recall Initiated
February 22, 2017
Posted
April 17, 2017
Terminated
August 7, 2017
Recall Number
Z-1835-2017
Quantity
87
Firm Location
Brockton, MA

Reason for Recall

Incorrect device was packaged.

Distribution

Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.

Lot / Code Info

Lot Number: 16100050

Root Cause

Labeling mix-ups

Action Taken

ACE sent a Customer Notice letter dated February 22, 2017 via certified mail to customers. The letter identified the affected product, problem, risk to health and actions to be taken. Customers were instructed to complete and return the enclosed Business Reply Form. For question call 1-800-441-3100 ext. 208.

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