FDA-Device2018-04-04Class II
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.
Zimmer Biomet, Inc.
Hazard
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.
Sold states
Non-USA Customer
Affected count
3 units
Manufactured in
1800 W Center St, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1224-2018Don't want to check this manually?
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