FDA recall Z-1510-2021

Product

CANNU-Flex SILK Interference Screws 6 mmx 30 mm - Product Usage: used for interference fixation of bone-tendon-bone of soft tissue grafts in anterior cruciate ligament reconstruction, Part Number: 014208

Reason for recall

Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw

Distribution

Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Australia, Japan.

Key facts

Status

Terminated

Initiation date

2021-04-08

Report date

2021-05-05

Termination date

2022-06-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1510-2021