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CPT®

Model 8114-12-18 · Zimmer, Inc. · DI 00889024145948

JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350

UDILibrary device dossier · generated 2026-09-08 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (4)

InitiatedRecall #ClassStatusReasonLink basis
2024-07-02Z-2450-2024Class IIOpen, ClassifiedAffected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.code info di
2016-01-11Z-0843-2016Class IITerminatedLDPE bag containing the implant adheres to the highly polished implant surface.k number procode
2016-01-11Z-1120-2016Class IITerminatedAs 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
2013-10-11Z-1032-2014Class IITerminatedZimmer 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.

12232019-01: 0 reports for this device; peer average 3.3/device2019-02: 0 reports for this device; peer average 2.66/device2019-03: 0 reports for this device; peer average 2.83/device2019-04: 0 reports for this device; peer average 2.75/device2019-05: 0 reports for this device; peer average 2.19/device2019-06: 0 reports for this device; peer average 1.9/device2019-07: 0 reports for this device; peer average 2.02/device2019-08: 0 reports for this device; peer average 2.09/device2019-09: 0 reports for this device; peer average 2.42/device2019-10: 0 reports for this device; peer average 2.46/device2019-11: 0 reports for this device; peer average 1.96/device2019-12: 0 reports for this device; peer average 2.32/device2020-01: 0 reports for this device; peer average 2.63/device2020-02: 0 reports for this device; peer average 2.55/device2020-03: 0 reports for this device; peer average 3.32/device2020-04: 0 reports for this device; peer average 2.14/device2020-05: 0 reports for this device; peer average 2.36/device2020-06: 0 reports for this device; peer average 1.89/device2020-07: 0 reports for this device; peer average 2.48/device2020-08: 0 reports for this device; peer average 1.89/device2020-09: 0 reports for this device; peer average 2.22/device2020-10: 0 reports for this device; peer average 2.44/device2020-11: 0 reports for this device; peer average 2.16/device2020-12: 0 reports for this device; peer average 2.16/device2021-01: 0 reports for this device; peer average 2.23/device2021-02: 0 reports for this device; peer average 1.95/device2021-03: 0 reports for this device; peer average 1.98/device2021-04: 0 reports for this device; peer average 1.88/device2021-05: 0 reports for this device; peer average 1.94/device2021-06: 0 reports for this device; peer average 2.35/device2021-07: 0 reports for this device; peer average 2.15/device2021-08: 0 reports for this device; peer average 1.92/device2021-09: 0 reports for this device; peer average 2.11/device2021-10: 0 reports for this device; peer average 1.98/device2021-11: 0 reports for this device; peer average 2.08/device2021-12: 0 reports for this device; peer average 2.29/device2022-01: 0 reports for this device; peer average 1.87/device2022-02: 0 reports for this device; peer average 2.34/device2022-03: 0 reports for this device; peer average 1.87/device2022-04: 0 reports for this device; peer average 2.13/device2022-05: 0 reports for this device; peer average 1.9/device2022-06: 0 reports for this device; peer average 2.02/device2022-07: 0 reports for this device; peer average 1.96/device2022-08: 0 reports for this device; peer average 2.07/device2022-09: 0 reports for this device; peer average 1.96/device2022-10: 0 reports for this device; peer average 1.99/device2022-11: 0 reports for this device; peer average 2.12/device2022-12: 0 reports for this device; peer average 2.02/device2023-01: 0 reports for this device; peer average 1.66/device2023-02: 0 reports for this device; peer average 1.87/device2023-03: 0 reports for this device; peer average 2.02/device2023-04: 0 reports for this device; peer average 1.93/device2023-05: 0 reports for this device; peer average 2.1/device2023-06: 0 reports for this device; peer average 2.12/device2023-07: 0 reports for this device; peer average 2.05/device2023-08: 0 reports for this device; peer average 2.02/device2023-09: 0 reports for this device; peer average 2.03/device2023-10: 0 reports for this device; peer average 1.5/device2023-11: 0 reports for this device; peer average 1.54/device2023-12: 0 reports for this device; peer average 1.57/device2024-01: 0 reports for this device; peer average 1.63/device2024-02: 0 reports for this device; peer average 1.82/device2024-03: 0 reports for this device; peer average 1.96/device2024-04: 0 reports for this device; peer average 1.66/device2024-05: 0 reports for this device; peer average 2.16/device2024-06: 0 reports for this device; peer average 1.89/device2024-07: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 1.84/device2024-09: 0 reports for this device; peer average 1.96/device2024-10: 0 reports for this device; peer average 1.6/device2024-11: 0 reports for this device; peer average 1.48/device2024-12: 0 reports for this device; peer average 1.48/device2025-01: 0 reports for this device; peer average 1.55/device2025-02: 0 reports for this device; peer average 1.41/device2025-03: 0 reports for this device; peer average 1.62/device2025-04: 0 reports for this device; peer average 1.71/device2025-05: 0 reports for this device; peer average 1.44/device2025-06: 0 reports for this device; peer average 1.69/device2025-07: 0 reports for this device; peer average 1.64/device2025-08: 0 reports for this device; peer average 1.47/device2025-09: 0 reports for this device; peer average 1.77/device2025-10: 0 reports for this device; peer average 1.67/device2025-11: 0 reports for this device; peer average 1.87/device2025-12: 0 reports for this device; peer average 1.85/device2026-01: 0 reports for this device; peer average 2.01/device2026-02: 0 reports for this device; peer average 1.55/device2026-03: 0 reports for this device; peer average 2.14/device2026-04: 0 reports for this device; peer average 1.79/device2026-05: 0 reports for this device; peer average 1.81/device2026-06: 0 reports for this device; peer average 1.65/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.3
2019-0202.66
2019-0302.83
2019-0402.75
2019-0502.19
2019-0601.9
2019-0702.02
2019-0802.09
2019-0902.42
2019-1002.46
2019-1101.96
2019-1202.32
2020-0102.63
2020-0202.55
2020-0303.32
2020-0402.14
2020-0502.36
2020-0601.89
2020-0702.48
2020-0801.89
2020-0902.22
2020-1002.44
2020-1102.16
2020-1202.16
2021-0102.23
2021-0201.95
2021-0301.98
2021-0401.88
2021-0501.94
2021-0602.35
2021-0702.15
2021-0801.92
2021-0902.11
2021-1001.98
2021-1102.08
2021-1202.29
2022-0101.87
2022-0202.34
2022-0301.87
2022-0402.13
2022-0501.9
2022-0602.02
2022-0701.96
2022-0802.07
2022-0901.96
2022-1001.99
2022-1102.12
2022-1202.02
2023-0101.66
2023-0201.87
2023-0302.02
2023-0401.93
2023-0502.1
2023-0602.12
2023-0702.05
2023-0802.02
2023-0902.03
2023-1001.5
2023-1101.54
2023-1201.57
2024-0101.63
2024-0201.82
2024-0301.96
2024-0401.66
2024-0502.16
2024-0601.89
2024-0701.67
2024-0801.84
2024-0901.96
2024-1001.6
2024-1101.48
2024-1201.48
2025-0101.55
2025-0201.41
2025-0301.62
2025-0401.71
2025-0501.44
2025-0601.69
2025-0701.64
2025-0801.47
2025-0901.77
2025-1001.67
2025-1101.87
2025-1201.85
2026-0102.01
2026-0201.55
2026-0302.14
2026-0401.79
2026-0501.81
2026-0601.65
This device (reports/month)Average device in JDI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K030265 — cited as predicate by K140547, K152530, K191735, K210842

K191735 — cites (transitively): K030265 (d1), K960658 (d1) — cited as predicate by K200823, K210842

K960658 — cited as predicate by K130610, K181761, K191735

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
  • OAI 2014-06-11 Zimmer Manufacturing B.V. · 9 citations
  • OAI 2014-05-28 Zimmer, Inc. · 12 citations
  • OAI 2014-05-28 Zimmer, Inc. · 12 citations
  • VAI 2014-02-07 Zimmer, Inc. · 2 citations
  • VAI 2014-02-07 Zimmer, Inc. · 2 citations
  • OAI 2013-08-19 Zimmer, Inc. · 0 citations