# P010014: Oxford (TM) Meniscal Unicompartmental Knee System

- Pathway: PMA
- Applicant: Biomet Manufacturing Corp
- Decided: Apr 21, 2004 after 1,147 days
- Product code: NRA (Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing)
- Device class: 3
- Recalls of this device: 22 (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
- Jan 5, 2016 · Class II · Z-1162-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1159-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1165-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1153-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1168-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1152-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1158-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1170-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1173-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1172-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1169-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1157-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1163-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1161-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1155-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1156-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1154-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1164-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1160-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Jan 5, 2016 · Class II · Z-1171-2017: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr
- Apr 22, 2011 · Not classified · Z-2698-2011: This recall was initiated due to a customer complaint which reported that while peeling off the Tyvek lid on the blister pack, very little effort was required to remove it and this could lead to conta
- Dec 19, 2008 · Not classified · Z-0962-2009: Packages labeled as "right" actually contain a "left" component.

Source page: https://510kreport.com/device/P010014
Methodology: https://510kreport.com/methodology