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BUCK

Model 71279424 · Smith & Nephew, Inc. · DI 03596010493620

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 (0)

No recalls linked in the loaded window.

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/device2021-07: 0 reports for this device; peer average 3/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 3/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/device2025-05: 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/device0203040708101205071112070905060809101101020406070809100103050810110102030405
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
2021-0703
2021-1101
2021-1201
2022-0703
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
2025-0501
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 LZN (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K211176 — cites (transitively): K002747 (d1), K002996 (d1), K021673 (d1), K021803 (d1), K022556 (d1), K022902 (d1), K022958 (d1), K023302 (d1), K023743 (d1), K033442 (d1), K040680 (d1), K052792 (d1), K070278 (d1), K070756 (d1), K071160 (d1), K072817 (d1), K072852 (d1), K081124 (d1), K083566 (d1), K083762 (d1), K092386 (d1), K093363 (d1), K093991 (d1), K100412 (d1), K100481 (d1), K102370 (d1), K103256 (d1), K110101 (d1), K110135 (d1), K113848 (d1), K120211 (d1), K121627 (d1), K122244 (d1), K122296 (d1), K123012 (d1), K130728 (d1), K143739 (d1), K150790 (d1), K151902 (d1), K160923 (d1), K162303 (d1), K171073 (d1), K171934 (d1), K182109 (d1), K182535 (d1), K791125 (d1), K823723 (d1), K823727 (d1), K831884 (d1), K896580 (d1), K900628 (d1), K914878 (d1), K920430 (d1), K921400 (d1), K932755 (d1), K934353 (d1), K960094 (d1), K962541 (d1), K963486 (d1), K963509 (d1), K970337 (d1), K970351 (d1), K971414 (d1), K983834 (d1), K990369 (d1), K990666 (d1), K991485 (d1), K061253 (d2), K062408 (d2), K071535 (d2), K082844 (d2), K062148 (d2), K083116 (d2), K050937 (d2), K060630 (d2), K113789 (d2), K042127 (d2), K052426 (d2), K954935 (d2), K961939 (d2), K102019 (d2), P040033 (d2), K111635 (d2), K122139 (d2), K162641 (d2), K061067 (d3), P960054 (d3), K033273 (d3), P960047 (d3) — cited as predicate by K231448, K240783, K242272, K250921

K791125 — cited as predicate by K152084, K210062, K211176

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Smith & Nephew, Inc.

  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2014-06-11 Smith & Nephew, Inc.
  • Warning Letter 2010-09-16 Ascension Orthopedics, Inc
  • NAI 2025-01-27 Integrity Orthopaedics Inc · 0 citations
  • NAI 2023-05-03 CARTIHEAL, LTD · 0 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • VAI 2020-02-06 Blue Belt Technologies, Inc · 6 citations
  • NAI 2019-10-25 Tusker Medical, Inc. · 0 citations
  • VAI 2019-10-08 Tusker Medical, Inc. · 3 citations
  • NAI 2018-03-30 Ascension Orthopedics, Inc · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-01-30 Smith & Nephew · 0 citations
  • NAI 2017-08-21 Smith & Nephew, Inc. Advanced Surgical Devices Division · 0 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations