INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
FDA Recall Z-1835-2017 · Posted 2017-04-17
Recalling FirmAce Surgical Supply Co., Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2017-02-22
Date Terminated2017-08-07
Product Quantity87
Reason for Recall
Incorrect device was packaged.
Firm Action
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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.