Z-1265-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2015
- Initiation Date
- January 23, 2015
- Termination Date
- May 20, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 130 units
Product Description
MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses.
Reason for Recall
Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa.
Distribution Pattern
US Nationwide Distribution.
Code Information
MAX-TL Lot# 1244041400 Z-MAX9-7 Lot# 1238041402