INFINITY Internal Hex Healing Abutment, 4.5mm Platform… recallZ-1835-2017 · Ace Surgical Supply Co., Inc. · initiated Feb 22, 2017
Class II Terminated All recalls posted in April 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ace Surgical Supply Co., Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect device was packaged.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-1835-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 22, 2017
- Posted by the FDA
- Apr 17, 2017
- Recalling firm
- Ace Surgical Supply Co., Inc.
- Quantity
- 87
- Product code
- DZE
- FDA submissions
- K093518
- Distribution
- Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.
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.
Code information (models, lots, serial numbers)
Lot Number: 16100050
Other devices under the same FDA submission
2 devices cleared under K093518 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- miniMark Dental Implant System 11321005Ace Surgical Supply CO., Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
- miniMark Dental Implant System 11321520Ace Surgical Supply CO., Inc. · IMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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