Recall Z-1835-2017 ยท DZE Implant, Endosseous, Root-Form
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.
| Date | Apr 17, 2017 (initiated Feb 22, 2017) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093518 | ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM Ace Surgical Supply Co., Inc., Jan 14, 2010 |