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Trilogy®
Model 6105-36-22 · Zimmer, Inc. · DI 00889024359574
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
MLR — Sterilizer, Chemical · Class II · 21 CFR 880.6860
UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (2)
Initiated
Recall #
Class
Status
Reason
Link basis
2016-01-11
Z-1160-2016
Class II
Terminated
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
k number procode
2013-10-11
Z-1024-2014
Class II
Terminated
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
k number procode
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
3.76
2019-02
0
3.21
2019-03
0
3.67
2019-04
0
3.35
2019-05
0
2.52
2019-06
0
2.12
2019-07
0
2.24
2019-08
0
2.51
2019-09
0
3.05
2019-10
0
3.39
2019-11
0
2.72
2019-12
0
3.09
2020-01
0
3.47
2020-02
0
3.09
2020-03
0
3.9
2020-04
0
2.73
2020-05
0
2.57
2020-06
0
2.57
2020-07
0
2.99
2020-08
0
2.38
2020-09
0
3.08
2020-10
0
3.04
2020-11
0
2.84
2020-12
0
2.76
2021-01
0
3.02
2021-02
0
2.41
2021-03
0
2.43
2021-04
0
2.57
2021-05
0
2.27
2021-06
0
3.07
2021-07
0
2.73
2021-08
0
2.8
2021-09
0
2.8
2021-10
0
2.49
2021-11
0
2.46
2021-12
0
2.77
2022-01
0
2.46
2022-02
0
2.14
2022-03
0
2.71
2022-04
0
2.5
2022-05
0
2.38
2022-06
0
2.72
2022-07
0
2.41
2022-08
0
2.52
2022-09
0
2.48
2022-10
0
2.45
2022-11
0
2.54
2022-12
0
2.66
2023-01
0
2.66
2023-02
0
2.56
2023-03
0
2.94
2023-04
0
2.71
2023-05
0
2.57
2023-06
0
2.59
2023-07
0
2.34
2023-08
0
2.21
2023-09
0
2.12
2023-10
0
1.93
2023-11
0
1.8
2023-12
0
1.94
2024-01
0
1.93
2024-02
0
2.35
2024-03
0
2.11
2024-04
0
1.94
2024-05
0
2.16
2024-06
0
2.08
2024-07
0
1.91
2024-08
0
2.02
2024-09
0
2.36
2024-10
0
2.02
2024-11
0
2.01
2024-12
0
1.67
2025-01
0
2.16
2025-02
0
1.65
2025-03
0
1.91
2025-04
0
1.93
2025-05
0
1.92
2025-06
0
2.02
2025-07
0
2.03
2025-08
0
1.87
2025-09
0
1.9
2025-10
0
1.82
2025-11
0
1.88
2025-12
0
2
2026-01
0
2.12
2026-02
0
1.78
2026-03
0
2.03
2026-04
0
1.95
2026-05
0
1.73
2026-06
0
1.88
This device (reports/month)Average device in LPH, MLR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K934765 — cited as predicate by K101472, K112898, K180798, K213842, K241636
K953490 — cited as predicate by K112898, K180798
Lineage extracted from public 510(k) summary text (heuristic).
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