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