FDA recall Z-0325-2018

Amendia, Inc · Class II · device

Product

Mac Pin Non-Cannulated Screw, 6.5 x 60mm

Reason for recall

Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.

Distribution

Distribution to Georgia, USA.

Key facts

Status
Terminated
Initiation date
2017-07-07
Report date
2018-01-17
Termination date
2019-10-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0325-2018