Print-ready dossier — use your browser's print dialog to save as PDF.
CODMAN®
Model 261221 · INTEGRA LIFESCIENCES PRODUCTION CORPORATION · DI 10381780513599
HBF — Drills, Burrs, Trephines & Accessories (Compound, Powered) · Class II · 21 CFR 882.4305
UDILibrary device dossier · generated 2026-09-13 · 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
2025-04-11
Z-1716-2025
Class I
Open, Classified
Inadequate weld that can potentially cause the product to disassemble.
code info di
Adverse-event reports — MAUDE (246)
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.
Malfunction: 160 · Injury: 86
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
15.5
2019-03
0
29
2019-04
0
15
2019-05
0
11.67
2019-06
0
14.33
2019-07
2
10.33
2019-08
0
15.67
2019-09
0
8.2
2019-10
0
15.33
2019-11
0
14.67
2019-12
0
13.25
2020-01
0
22
2020-02
0
20
2020-03
0
20.5
2020-04
0
34
2020-05
0
6
2020-06
1
6.7
2020-07
1
7.57
2020-08
0
8.33
2020-09
0
10.4
2020-10
0
6.55
2020-11
0
10.33
2020-12
0
8.71
2021-01
0
6.67
2021-02
0
5.71
2021-03
0
7.4
2021-04
0
9.17
2021-05
2
7.67
2021-06
0
6.78
2021-07
2
6.2
2021-08
0
10.4
2021-09
1
11.8
2021-10
0
9.75
2021-11
2
5.5
2021-12
2
8.25
2022-01
0
15.5
2022-02
3
4.36
2022-03
7
8.14
2022-04
0
7.4
2022-05
10
6
2022-06
7
10.17
2022-07
9
14
2022-08
3
6.63
2022-09
5
14
2022-10
5
9.33
2022-11
5
8.17
2022-12
2
11.75
2023-01
3
10
2023-02
2
8.2
2023-03
4
8.25
2023-04
4
9
2023-05
6
10.75
2023-06
12
11.2
2023-07
5
9.67
2023-08
7
6.67
2023-09
1
6.4
2023-10
4
7.25
2023-11
3
14
2023-12
3
6.25
2024-01
15
14.75
2024-02
14
5.6
2024-03
10
7.75
2024-04
9
5.2
2024-05
7
3.6
2024-06
14
7
2024-07
4
5.17
2024-08
5
5
2024-09
6
8
2024-10
5
7.33
2024-11
4
3.8
2024-12
2
4.83
2025-01
2
5.4
2025-02
1
3
2025-03
1
4.2
2025-04
2
3.83
2025-05
1
2.6
2025-06
2
4.33
2025-07
3
6.25
2025-08
3
5.33
2025-09
3
3
2025-10
4
3.2
2025-11
0
3.43
2025-12
0
3
2026-01
2
3
2026-02
2
2.75
2026-03
2
2.6
2026-04
0
6
2026-05
0
3.33
2026-06
0
3
This device (reports/month)Average device in HBF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K791101 — cited as predicate by K183581
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — INTEGRA LIFESCIENCES PRODUCTION CORPORATION