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Unnamed device
Model 5049-11 · Zimmer, Inc. · DI 00889024376564
JDZ — Mixer, Cement, For Clinical Use · Class I · 21 CFR 888.4210
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 (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2026-03-30
Z-1946-2026
Class II
Open, Classified
Ten complaints have been received identifying issues at the time of use related to the package seal,
including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.
code info di
Adverse-event reports — MAUDE (390)
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: 386 · Injury: 4
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
2.25
2019-02
0
4.5
2019-03
0
1.5
2019-04
0
8
2019-05
0
2.67
2019-06
0
6
2019-07
0
3
2019-08
0
10.25
2019-09
0
23.5
2019-10
0
16.4
2019-11
0
36
2019-12
0
26.5
2020-01
0
23
2020-02
0
9.5
2020-03
2
10.33
2020-04
0
2.8
2020-05
28
15.5
2020-06
25
24
2020-07
1
3.17
2020-08
4
4.5
2020-09
0
7
2020-10
1
1.67
2020-11
0
14
2020-12
0
14
2021-01
0
3
2021-02
0
14
2021-03
9
19.67
2021-04
9
12
2021-05
0
18
2021-06
2
4
2021-07
20
20
2021-08
0
10
2021-09
0
4.5
2021-10
0
2.5
2021-11
0
3.5
2021-12
0
3
2022-01
0
1
2022-02
17
9.5
2022-03
0
2
2022-04
1
1.2
2022-05
0
2
2022-06
0
4
2022-07
0
2.75
2022-08
0
2
2022-09
1
1.25
2022-10
0
2.75
2022-11
1
1
2022-12
1
2.33
2023-01
0
1
2023-02
0
2
2023-04
0
1.67
2023-05
0
2
2023-06
0
2.25
2023-07
1
1.14
2023-08
3
5
2023-09
26
10
2023-10
0
1
2023-11
4
2
2023-12
1
1
2024-01
8
3.67
2024-02
0
2
2024-03
0
1.33
2024-04
0
1
2024-05
0
2
2024-06
3
3
2024-07
1
1
2024-09
0
2.5
2024-10
0
1.25
2024-11
0
5
2024-12
1
1
2025-01
0
1.17
2025-03
0
2
2025-04
0
1.33
2025-05
0
3
2025-06
0
2.67
2025-07
0
1
2025-08
0
1
2025-10
0
1
2025-12
0
1
2026-01
1
1
2026-02
5
2.67
2026-03
85
23.75
2026-04
108
55
2026-05
20
7.33
2026-06
1
1
This device (reports/month)Average device in JDZ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Zimmer, Inc.
Warning Letter 2016-05-27 Orthosoft, Inc.
Warning Letter 2012-09-19 Zimmer Manufacturing B.V.
NAI 2022-07-27 Zimmer, Inc. · 0 citations
NAI 2022-07-27 Zimmer, Inc. · 0 citations
NAI 2020-10-01 Zimmer Manufacturing B.V. · 0 citations
VAI 2017-10-16 Zimmer, Inc. · 8 citations
VAI 2017-10-16 Zimmer, Inc. · 8 citations
NAI 2017-09-01 Zimmer Trabecular Metal Technology, Inc. · 0 citations
VAI 2017-07-27 ZIMMER ORTHOPEDIC MFG LTD · 3 citations
VAI 2017-07-20 Zimmer Manufacturing B.V. · 3 citations
VAI 2016-05-23 Zimmer Surgical Inc · 4 citations
OAI 2015-11-20 Zimmer, Inc. · 10 citations
OAI 2015-11-20 Zimmer, Inc. · 10 citations
VAI 2015-11-17 Zimmer Manufacturing B.V. · 4 citations
VAI 2015-05-11 Zimmer Trabecular Metal Technology, Inc. · 3 citations
VAI 2014-10-16 ZIMMER ORTHOPEDIC MFG LTD · 2 citations