Z-1009-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- October 25, 2017
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 429 units
Product Description
fastener, fixation, nondegradable, soft tissue
Reason for Recall
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
Distribution Pattern
TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT
Code Information
Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370