Compress® Device
Model 178711 · Biomet Orthopedics, LLC · DI 00880304430792
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
UDILibrary device dossier · generated 2026-09-14 · 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. | k number procode |
Adverse-event reports — MAUDE (8)
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.
Injury: 8
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.77 |
| 2019-02 | 0 | 2.43 |
| 2019-03 | 1 | 2.68 |
| 2019-04 | 0 | 2.56 |
| 2019-05 | 0 | 2.07 |
| 2019-06 | 0 | 1.79 |
| 2019-07 | 0 | 1.79 |
| 2019-08 | 0 | 2.06 |
| 2019-09 | 0 | 2.19 |
| 2019-10 | 0 | 2.37 |
| 2019-11 | 0 | 2 |
| 2019-12 | 0 | 2.31 |
| 2020-01 | 0 | 2.62 |
| 2020-02 | 0 | 2.38 |
| 2020-03 | 0 | 2.94 |
| 2020-04 | 0 | 2.15 |
| 2020-05 | 0 | 2.15 |
| 2020-06 | 0 | 1.98 |
| 2020-07 | 0 | 2.35 |
| 2020-08 | 0 | 1.93 |
| 2020-09 | 0 | 2.37 |
| 2020-10 | 0 | 2.41 |
| 2020-11 | 0 | 2.18 |
| 2020-12 | 0 | 2.17 |
| 2021-01 | 0 | 2.28 |
| 2021-02 | 0 | 1.94 |
| 2021-03 | 1 | 1.96 |
| 2021-04 | 0 | 1.96 |
| 2021-05 | 0 | 1.93 |
| 2021-06 | 1 | 2.28 |
| 2021-07 | 0 | 2.22 |
| 2021-08 | 0 | 2.18 |
| 2021-09 | 0 | 2.28 |
| 2021-10 | 0 | 2.11 |
| 2021-11 | 0 | 2.05 |
| 2021-12 | 0 | 2.21 |
| 2022-01 | 0 | 2.03 |
| 2022-02 | 0 | 2.14 |
| 2022-03 | 0 | 2.03 |
| 2022-04 | 0 | 2.1 |
| 2022-05 | 0 | 2.04 |
| 2022-06 | 1 | 2.15 |
| 2022-07 | 0 | 2.01 |
| 2022-08 | 0 | 2.09 |
| 2022-09 | 0 | 2.06 |
| 2022-10 | 0 | 2.02 |
| 2022-11 | 0 | 2.16 |
| 2022-12 | 0 | 2.06 |
| 2023-01 | 0 | 2.09 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 2.16 |
| 2023-04 | 0 | 2.11 |
| 2023-05 | 0 | 2.07 |
| 2023-06 | 0 | 2.17 |
| 2023-07 | 0 | 2.04 |
| 2023-08 | 0 | 1.89 |
| 2023-09 | 0 | 1.85 |
| 2023-10 | 0 | 1.59 |
| 2023-11 | 0 | 1.58 |
| 2023-12 | 0 | 1.6 |
| 2024-01 | 0 | 1.73 |
| 2024-02 | 0 | 1.95 |
| 2024-03 | 0 | 1.83 |
| 2024-04 | 1 | 1.71 |
| 2024-05 | 0 | 1.96 |
| 2024-06 | 0 | 1.85 |
| 2024-07 | 0 | 1.66 |
| 2024-08 | 0 | 1.79 |
| 2024-09 | 0 | 1.96 |
| 2024-10 | 0 | 1.72 |
| 2024-11 | 0 | 1.67 |
| 2024-12 | 1 | 1.56 |
| 2025-01 | 0 | 1.81 |
| 2025-02 | 0 | 1.52 |
| 2025-03 | 0 | 1.77 |
| 2025-04 | 1 | 1.77 |
| 2025-05 | 0 | 1.71 |
| 2025-06 | 1 | 1.8 |
| 2025-07 | 0 | 1.75 |
| 2025-08 | 0 | 1.66 |
| 2025-09 | 0 | 1.65 |
| 2025-10 | 0 | 1.67 |
| 2025-11 | 0 | 1.77 |
| 2025-12 | 0 | 1.93 |
| 2026-01 | 0 | 1.93 |
| 2026-02 | 0 | 1.64 |
| 2026-03 | 0 | 1.87 |
| 2026-04 | 0 | 1.81 |
| 2026-05 | 0 | 1.68 |
| 2026-06 | 0 | 1.67 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K043547 — cited as predicate by K101475
K112905 — cites (transitively): K020045 (d1), K033280 (d1), K062998 (d1) — cited as predicate by K123297, K173411, K183553
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC
Nothing in the loaded window.