Device product
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
Z-2876-2018
Product summary
- Event
- Event 80548
- Status
- Terminated
- Classification
- Class II
- Quantity
- 385
- Official record key
device-enforcement:Z-2876-2018
Official wording
Reason: 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.
Code information: 63465803, 63762260, 63767434, 63799794
Distribution pattern: Worldwide Distribution - Nationwide distribution and the countries of Japan and Netherlands.
Derived failure modes
-
Unknown
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.