FDA Medical Device Recalls (openFDA)
Ace Surgical Supply Co., Inc.: INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
- Recall number
- Z-1835-2017
- 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.
- Status
- Terminated
- Initiated
- 2017-02-22
- Posted
- 2017-04-17
- Terminated
- 2017-08-07
- Reason
- Incorrect device was packaged.
- 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
- 87
- Distribution
- Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.
- Lot, serial or model codes
- Lot Number: 16100050
- 510(k) numbers
- ["K093518"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1287163
- Firm city
- Brockton
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28