Z-0325-2018 Class II Terminated
FDA device recall Z-0325-2018 was initiated by Amendia, Inc on July 7, 2017 and is designated Class II. 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. The recall status is terminated (terminated October 15, 2019). Affected quantity: 41 screws.
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2018
- Initiation Date
- July 7, 2017
- Termination Date
- October 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 screws
Product Description
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 Pattern
Distribution to Georgia, USA.
Code Information
Model #85-6560-1, Lot #132117