Device product
Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product 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
Z-0708-2019
Product summary
- Event
- Event 81704
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 pieces
- Official record key
device-enforcement:Z-0708-2019
Official wording
Reason: 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
Code information: LOT 029980 UDI (01)00880304535589(17)280501(10)029980
Distribution pattern: Country of Japan
Derived failure modes
-
Unknown
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