# P060037: Nexgen LPS-Flex Mobile and LPS-Mobile Bearing Knee System

- Pathway: PMA
- Applicant: Zimmer, Inc.
- Decided: Dec 10, 2007 after 357 days
- Product code: NJL (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing)
- Device class: 3
- Recalls of this device: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0324-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Nov 29, 2017 · Class II · Z-1035-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1036-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1043-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1044-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1045-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1038-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Nov 29, 2017 · Class II · Z-1040-2018: The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed fro
- Jul 24, 2017 · Class II · Z-0663-2018: There is a possibility that the protective foam insert used during the packaging of the affected products is undersized, which may cause a breach in the inner cavity during transportation.
- Jan 11, 2016 · Class II · Z-0841-2016: LDPE bag containing the implant adheres to the highly polished implant surface.
- Aug 30, 2013 · Class II · Z-0080-2014: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
- Apr 17, 2009 · Not classified · Z-1522-2009: The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.
- Apr 17, 2009 · Not classified · Z-1520-2009: The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.
- Apr 17, 2009 · Not classified · Z-1521-2009: The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.
- Apr 17, 2009 · Not classified · Z-1523-2009: The implant surface may not have been polished adequately, which could result in increased wear and polyethylene debris generation.

Source page: https://510kreport.com/device/P060037
Methodology: https://510kreport.com/methodology