Device product

Biomet 8.0 Cannulated Screw Tap-Bone fixation screw Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.

Z-2304-2020

May 14, 2020

Class II

Product summary

Firm: Biomet
Event: Event 85701
Status: Terminated
Classification: Class II
Quantity: 10 OUS
Official record key: device-enforcement:Z-2304-2020

Official wording

Reason: Distributed to the field without having completed design history files or design transfer activities

Code information: Lot Number: 624830 (01)00887868133749(17)260414(10)624830 867210 (01)00887868133749(17)260730(10)867210

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
reason.no_named_rule · v1.0.0

Distributed to the field without having completed design history files or design transfer activities