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Oxford Partial Knee System
Model 159575 · Biomet Uk Ltd · DI 05019279786213
NRA — Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing · Class III
UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2020-04-17
Z-2148-2020
Class II
Terminated
Potential presence of elevated endotoxin levels that exceed the specification limit
code info di
Adverse-event reports — MAUDE (87)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Injury: 79 · Malfunction: 8
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
1
1.9
2019-02
2
1.67
2019-03
0
1.12
2019-04
2
1.52
2019-05
0
1.23
2019-06
0
1.89
2019-07
4
2.52
2019-08
4
2
2019-09
2
2.33
2019-10
0
1.37
2019-11
2
1.77
2019-12
0
2.13
2020-01
2
1.5
2020-02
0
1.5
2020-03
0
1.82
2020-04
2
1.73
2020-05
0
1.67
2020-06
0
1.82
2020-07
2
2.14
2020-08
2
1.55
2020-09
0
1.93
2020-10
0
1.78
2020-11
1
1.3
2020-12
0
2.29
2021-01
0
2
2021-02
1
1.25
2021-03
0
1.38
2021-04
0
1.55
2021-05
0
2.31
2021-06
2
1.85
2021-07
0
2.29
2021-08
2
1.8
2021-09
0
1.84
2021-10
4
1.9
2021-11
1
2.11
2021-12
0
1.63
2022-01
0
2.29
2022-02
0
2.27
2022-03
0
1.6
2022-04
0
1.85
2022-05
0
2
2022-06
0
2.53
2022-07
4
2.23
2022-08
0
2.1
2022-09
2
2.2
2022-10
2
2.29
2022-11
2
2
2022-12
0
2
2023-01
0
2.36
2023-02
2
2.78
2023-03
1
1.92
2023-04
6
3.92
2023-05
0
3
2023-06
0
2.23
2023-07
3
2.19
2023-08
2
2.5
2023-09
0
2.17
2023-10
0
2.1
2023-11
0
2.67
2023-12
0
2.63
2024-01
0
1.71
2024-02
0
1.19
2024-03
0
2.22
2024-04
6
2.33
2024-05
1
1.92
2024-06
4
2.75
2024-07
2
2.33
2024-08
2
2.08
2024-09
0
2
2024-10
3
1.78
2024-11
0
2.44
2024-12
3
1.8
2025-01
0
2.2
2025-02
3
2.25
2025-03
0
1.89
2025-04
0
1.38
2025-05
0
1.56
2025-06
0
1.83
2025-07
0
2.08
2025-08
1
1.67
2025-09
0
1.4
2025-10
0
2.2
2025-11
0
2
2025-12
2
2.9
2026-01
0
2.38
2026-02
0
2.71
2026-03
0
2
2026-04
0
3.36
2026-05
0
1.67
2026-06
0
1.83
This device (reports/month)Average device in NRA (reports/device/month)