Recall Z-1835-2017— Ace Surgical Supply Co., Inc.

Name: FDA recall Z-1835-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-22

Class II · Terminated

Class II FDA medical device recall by Ace Surgical Supply Co., Inc., initiated 2017-02-22, terminated 2017-08-07. It names one FDA 510(k) clearance: K093518. Product: INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.. Reason: Incorrect device was packaged..

Recalling firm: Ace Surgical Supply Co., Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-02-22
Terminated: 2017-08-07
Firm location: Brockton, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K093518 — ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEMAce Surgical Supply Co., Inc.·cleared 2010-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Incorrect device was packaged.

Data sourced from openFDA. This site is unofficial and independent of the FDA.