Z-1835-2017 Class II Terminated
FDA device recall Z-1835-2017 was initiated by Ace Surgical Supply Co., Inc. on February 22, 2017 and is designated Class II. Reason for recall: Incorrect device was packaged. The recall status is terminated (terminated August 7, 2017). Affected quantity: 87.
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- February 22, 2017
- Termination Date
- August 7, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 87
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.
Reason for Recall
Incorrect device was packaged.
Distribution Pattern
Nationwide Distribution in the states of CA, CT, FL, NY, OH, PA, and UT.
Code Information
Lot Number: 16100050