COMPRESS DEVICE
Model 178789 · Biomet Orthopedics, LLC · DI 00880304554931
JDC — Prosthesis, Elbow, Constrained, Cemented · Class II · 21 CFR 888.3150
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3510
KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660
KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650
KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390
KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer · Class II · 21 CFR 888.3310
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3670
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353
PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660
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 |
|---|---|---|---|---|---|
| 2019-08-21 | Z-0519-2020 | Class II | Terminated | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. | 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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.76 |
| 2019-02 | 0 | 2.42 |
| 2019-03 | 0 | 2.66 |
| 2019-04 | 0 | 2.56 |
| 2019-05 | 0 | 2.09 |
| 2019-06 | 0 | 1.79 |
| 2019-07 | 0 | 1.81 |
| 2019-08 | 0 | 2.08 |
| 2019-09 | 0 | 2.19 |
| 2019-10 | 0 | 2.35 |
| 2019-11 | 0 | 2 |
| 2019-12 | 0 | 2.28 |
| 2020-01 | 0 | 2.59 |
| 2020-02 | 0 | 2.36 |
| 2020-03 | 0 | 2.93 |
| 2020-04 | 0 | 2.14 |
| 2020-05 | 0 | 2.14 |
| 2020-06 | 0 | 1.98 |
| 2020-07 | 0 | 2.38 |
| 2020-08 | 0 | 1.93 |
| 2020-09 | 0 | 2.35 |
| 2020-10 | 0 | 2.41 |
| 2020-11 | 0 | 2.17 |
| 2020-12 | 0 | 2.16 |
| 2021-01 | 0 | 2.3 |
| 2021-02 | 0 | 1.96 |
| 2021-03 | 0 | 1.99 |
| 2021-04 | 0 | 1.98 |
| 2021-05 | 0 | 1.96 |
| 2021-06 | 0 | 2.28 |
| 2021-07 | 0 | 2.23 |
| 2021-08 | 0 | 2.19 |
| 2021-09 | 0 | 2.28 |
| 2021-10 | 0 | 2.14 |
| 2021-11 | 0 | 2.07 |
| 2021-12 | 0 | 2.29 |
| 2022-01 | 0 | 2.11 |
| 2022-02 | 0 | 2.18 |
| 2022-03 | 0 | 2.12 |
| 2022-04 | 0 | 2.17 |
| 2022-05 | 0 | 2.07 |
| 2022-06 | 0 | 2.18 |
| 2022-07 | 0 | 2.03 |
| 2022-08 | 0 | 2.12 |
| 2022-09 | 0 | 2.08 |
| 2022-10 | 0 | 2.05 |
| 2022-11 | 0 | 2.17 |
| 2022-12 | 0 | 2.1 |
| 2023-01 | 0 | 2.09 |
| 2023-02 | 0 | 2.02 |
| 2023-03 | 0 | 2.17 |
| 2023-04 | 0 | 2.15 |
| 2023-05 | 0 | 2.09 |
| 2023-06 | 0 | 2.19 |
| 2023-07 | 0 | 2.05 |
| 2023-08 | 0 | 1.89 |
| 2023-09 | 0 | 1.84 |
| 2023-10 | 0 | 1.6 |
| 2023-11 | 0 | 1.6 |
| 2023-12 | 0 | 1.59 |
| 2024-01 | 0 | 1.73 |
| 2024-02 | 0 | 1.96 |
| 2024-03 | 0 | 1.83 |
| 2024-04 | 0 | 1.74 |
| 2024-05 | 0 | 1.94 |
| 2024-06 | 0 | 1.86 |
| 2024-07 | 0 | 1.66 |
| 2024-08 | 0 | 1.79 |
| 2024-09 | 0 | 1.95 |
| 2024-10 | 0 | 1.74 |
| 2024-11 | 0 | 1.67 |
| 2024-12 | 0 | 1.57 |
| 2025-01 | 0 | 1.81 |
| 2025-02 | 0 | 1.54 |
| 2025-03 | 0 | 1.8 |
| 2025-04 | 0 | 1.78 |
| 2025-05 | 0 | 1.73 |
| 2025-06 | 0 | 1.83 |
| 2025-07 | 0 | 1.77 |
| 2025-08 | 0 | 1.66 |
| 2025-09 | 0 | 1.64 |
| 2025-10 | 0 | 1.68 |
| 2025-11 | 0 | 1.77 |
| 2025-12 | 0 | 1.96 |
| 2026-01 | 0 | 1.94 |
| 2026-02 | 0 | 1.67 |
| 2026-03 | 0 | 1.88 |
| 2026-04 | 0 | 1.81 |
| 2026-05 | 0 | 1.7 |
| 2026-06 | 0 | 1.7 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K112905 — cites (transitively): K020045 (d1), K033280 (d1), K062998 (d1) — cited as predicate by K123297, K173411, K183553
K123297 — cites (transitively): K112905 (d1), K020045 (d2), K033280 (d2), K062998 (d2) — cited as predicate by K183553
K173411 — cites (transitively): K052906 (d1), K060704 (d1), K080642 (d1), K111746 (d1), K112905 (d1), K113069 (d1), K113121 (d1), K120121 (d1), K121543 (d1), K122692 (d1), K130661 (d1), K131353 (d1), K133378 (d1), K143659 (d1), K152754 (d1), K153398 (d1), K020045 (d2), K030710 (d2), K033280 (d2), K042321 (d2), K043505 (d2), K622079 (d2), K925613 (d2), K062998 (d2), K123862 (d2), K001989 (d3) — cited as predicate by K191318, K223631
K183553 — cites (transitively): K101475 (d1), K112905 (d1), K123297 (d1), K043547 (d2), K062998 (d2), K020045 (d2), K033280 (d2)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC
Nothing in the loaded window.