INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage:
FDA device recall Z-1835-2017 · posted 2017-04-17 · Terminated
Recall details
- Recalling firm
- Ace Surgical Supply Co., Inc.
- Reason for recall
- Incorrect device was packaged.
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 87
- Distribution
- Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.
- Date initiated
- 2017-02-22
- Date posted
- 2017-04-17
- Date terminated
- 2017-08-07
- Location
- Brockton, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM (K093518) | Ace Surgical Supply Co., Inc. | 2010-01-14 |