CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report

Infinity Internal Hex Healing Abutment Platform CW- CH Straight recalled

Ace Surgical Supply is recalling Infinity Internal Hex Healing Abutment Platform CW- CH Straight, distributed nationwide in the US. The recall was initiated on 22 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 16100050

Quantity recalled87

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1835-2017
FDA event ID: 76604
Recalling firm: Ace Surgical Supply, Brockton, MA
Classification: Class II
Status: Terminated
Recall initiated: 22 Feb 2017
FDA classified: 17 Apr 2017
Reported: 26 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Dental Devices

Timeline

22 Feb 2017	Recall initiated by company
17 Apr 2017	Classified by FDA	+54 days
26 Apr 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect device was packaged.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide California Connecticut Florida New York Ohio Pennsylvania Utah

Questions about this recall

Why was it recalled?

Incorrect device was packaged.

Which lots are affected?

Lot Number: 16100050

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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