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BIOSTOP

Model 5463-20-000 · DEPUY ORTHOPAEDICS, INC. · DI 10603295174608

JDK — Prosthesis, Hip, Cement Restrictor · Class II · 21 CFR 878.3300

LZN — Cement Obturator · Class II · 21 CFR 878.3300

UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2022-12-19Z-0951-2023Class IIOpen, ClassifiedAll lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.code info di

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.

12232019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 3/device2019-12: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 2.33/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1.5/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 1/device020304070810120506071112070905060809101101020406070809100103040506070810110102030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0302
2019-0402
2019-0701
2019-0801
2019-1003
2019-1202
2021-0503
2021-0603
2021-0702.33
2021-1101
2021-1201
2022-0702
2022-0902
2023-0503
2023-0601
2023-0801
2023-0901
2023-1002
2023-1102
2024-0101
2024-0202
2024-0402
2024-0601
2024-0701
2024-0801
2024-0902
2024-1001
2025-0101
2025-0302
2025-0401
2025-0501
2025-0601
2025-0701
2025-0802
2025-1001
2025-1101.5
2026-0101
2026-0201.5
2026-0302
2026-0402
2026-0501
This device (reports/month)Average device in JDK, LZN (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — DEPUY ORTHOPAEDICS, INC.

  • Warning Letter 2011-12-08 DePuy Orthopaedics, Inc.
  • Warning Letter 2010-08-19 DePuy Orthopaedics, Inc.
  • NAI 2024-03-28 DePuy Orthopaedics, Inc. · 0 citations
  • NAI 2022-05-12 DePuy Orthopaedics, Inc. · 0 citations
  • NAI 2019-11-08 DePuy Orthopaedics, Inc. · 0 citations
  • VAI 2017-09-01 DePuy Orthopaedics, Inc. · 2 citations
  • VAI 2015-10-01 DePuy Orthopaedics, Inc. · 2 citations
  • NAI 2015-09-24 DePuy Orthopaedics, Inc. · 0 citations
  • VAI 2012-11-26 DePuy Orthopaedics, Inc. · 6 citations
  • NAI 2011-08-16 DePuy Orthopaedics, Inc. · 0 citations
  • OAI 2011-06-07 DePuy Orthopaedics, Inc. · 6 citations