Z-0709-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 16, 2019
- Initiation Date
- November 20, 2018
- Termination Date
- April 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 pieces
Product Description
Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone
Reason for Recall
One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 029980) contains 18mm locking screws
Distribution Pattern
Country of Japan
Code Information
LOT 029970 UDI (01)00880304535572(17)280501(10)029970