Device product
Biomet 6.5 Cannulated Screw Tap - Bone fixation screw, Item Number: 110008466 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Z-2303-2020
Product summary
- Firm
- Biomet
- Event
- Event 85701
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 OUS
- Official record key
device-enforcement:Z-2303-2020
Official wording
Reason: Distributed to the field without having completed design history files or design transfer activities
Code information: Lot Number: 624820 (01)00887868133732(17)260415(10)624820 867200 (01)00887868133732(17)260731(10)867200
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of NY, GA, FL, MO and the countries of Canada, AUSTRALIA, CHILE, CHINA, JAPAN, MALAYSIA, NETHERLANDS.
Derived failure modes
-
Unknown
Distributed to the field without having completed design history files or design transfer activities