FDA Device

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

Hazard

Incorrect device was packaged.

What You Should Do

Remedy

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.

Products

INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
Brand
Ace Surgical Supply Co., Inc.
UPC
Lot Number: 16100050

Units Affected

87