Z-1224-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 4, 2018
- Initiation Date
- December 12, 2017
- Termination Date
- April 9, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
PERSONA¿ THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Reason for Recall
A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.
Distribution Pattern
Non-USA Customer
Code Information
Item# 42-5320-067-02 Lot # 63236047