Z-1835-2017Class II

INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight

Name: Z-1835-2017 INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight
Creator: Ace Surgical Supply Co., Inc.
Published: 2017-02-22
License: https://open.fda.gov/license/

Ace Surgical Supply Co., Inc. / initiated 2017-02-22 / Terminated / root cause: labeling and UDI

FDA source

Ace Surgical Supply Co., Inc. began a recall of INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment on 2017-02-22. FDA classified it as Class II and gives the reason as "Incorrect device was packaged". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1835-2017
Classification: Class II
Status: Terminated
Initiated: 2017-02-22
Posted: 2017-04-17
Terminated: 2017-08-07
Recalling firm: Ace Surgical Supply Co., Inc.
Product: INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Incorrect device was packaged.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 87
Distribution: Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.
Product codes and lots: Lot Number: 16100050

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1835-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1835-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-17

Product code DZE

K093518Class IIAce Surgical Secure Locator 3.25 Implant SystemAce Surgical Supply Co., Inc. / cleared 2010-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)