Z-2876-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2018
- Initiation Date
- June 22, 2018
- Termination Date
- October 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 385
Product Description
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
Reason for Recall
The PPK System Spacer Block Alignment Tower mating feature that mates with the spacer block was undersized, which could potentially lead to mating issues between the devices. This could cause a delay in surgery of less than 30 minutes. There is an option in the surgical technique for performing limb alignment without the alignment tower.
Distribution Pattern
Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands.
Code Information
63465803, 63762260, 63767434, 63799794