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ALLOGENIX PLUS
Model 02-2902 · BIOMET MICROFIXATION, INC · DI 00841036181468
GXP — Methyl Methacrylate For Cranioplasty · Class II · 21 CFR 882.5300
MBP — Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) · Class II · 21 CFR 888.3045
MQV — Filler, Bone Void, Calcium Compound · Class II · 21 CFR 888.3045
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1
2019-02
0
2
2019-03
0
1.67
2019-04
0
1
2019-05
0
2.33
2019-06
0
1
2019-07
0
1
2019-09
0
1
2019-11
0
1
2019-12
0
1.86
2020-01
0
1.43
2020-02
0
1
2020-03
0
1
2020-04
0
1.25
2020-05
0
1
2020-06
0
1
2020-07
0
1
2020-08
0
3.17
2020-09
0
1
2020-10
0
1.25
2020-11
0
2
2020-12
0
1
2021-02
0
1.6
2021-03
0
2.17
2021-04
0
1.33
2021-05
0
1.67
2021-06
0
1.5
2021-07
0
2.14
2021-08
0
2
2021-09
0
1
2021-10
0
1
2021-11
0
2.5
2021-12
0
2.25
2022-01
0
1
2022-02
0
3
2022-03
0
2.67
2022-04
0
1
2022-05
0
1
2022-06
0
2
2022-08
0
2
2022-09
0
2.33
2022-10
0
5.8
2022-11
0
2
2023-01
0
2
2023-02
0
1.5
2023-03
0
4
2023-04
0
1.75
2023-05
0
1
2023-07
0
1.33
2023-08
0
1.33
2023-09
0
4
2024-01
0
3
2024-02
0
1.14
2024-03
0
2
2024-04
0
1.67
2024-05
0
1
2024-06
0
2
2024-07
0
1.43
2024-08
0
2
2024-10
0
1.6
2024-12
0
1
2025-01
0
1.67
2025-03
0
1.67
2025-04
0
1
2025-06
0
4.4
2025-07
0
1.82
2025-08
0
2
2025-09
0
1
2025-10
0
1
2025-11
0
1.5
2025-12
0
1
2026-01
0
1.88
2026-02
0
1.6
2026-03
0
1.2
2026-04
0
1
2026-05
0
2.5
2026-06
0
1
This device (reports/month)Average device in GXP, MBP, MQV (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — BIOMET MICROFIXATION, INC
VAI 2025-03-04 Zimmer Biomet CMF and Thoracic LLC · 3 citations
VAI 2018-05-24 Zimmer Biomet CMF and Thoracic LLC · 1 citations
VAI 2017-09-01 Zimmer Biomet CMF and Thoracic LLC · 3 citations
VAI 2015-10-30 Zimmer Biomet CMF and Thoracic LLC · 1 citations
VAI 2012-01-17 Zimmer Biomet CMF and Thoracic LLC · 2 citations