Comprehensive Reverse Shoulder
Model 010000589 · Biomet Orthopedics, LLC · DI 00880304532465
KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660
PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660
UDILibrary device dossier · generated 2026-09-15 · 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 |
|---|---|---|---|---|---|
| 2020-09-02 | Z-0093-2021 | Class II | Terminated | Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters | code info di |
Adverse-event reports — MAUDE (140)
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: 135 · Malfunction: 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.82 |
| 2019-02 | 0 | 1.85 |
| 2019-03 | 0 | 1.75 |
| 2019-04 | 0 | 1.88 |
| 2019-05 | 0 | 2.1 |
| 2019-06 | 0 | 1.88 |
| 2019-07 | 0 | 1.68 |
| 2019-08 | 0 | 2.18 |
| 2019-09 | 1 | 1.67 |
| 2019-10 | 0 | 1.88 |
| 2019-11 | 2 | 1.72 |
| 2019-12 | 0 | 1.77 |
| 2020-01 | 0 | 1.96 |
| 2020-02 | 1 | 2.08 |
| 2020-03 | 2 | 2.19 |
| 2020-04 | 2 | 1.8 |
| 2020-05 | 0 | 1.66 |
| 2020-06 | 1 | 1.95 |
| 2020-07 | 0 | 2.24 |
| 2020-08 | 0 | 1.76 |
| 2020-09 | 1 | 1.96 |
| 2020-10 | 2 | 2.2 |
| 2020-11 | 0 | 1.9 |
| 2020-12 | 0 | 1.87 |
| 2021-01 | 0 | 2.2 |
| 2021-02 | 1 | 1.99 |
| 2021-03 | 4 | 2.15 |
| 2021-04 | 1 | 2.02 |
| 2021-05 | 2 | 2.02 |
| 2021-06 | 0 | 1.91 |
| 2021-07 | 3 | 2.06 |
| 2021-08 | 2 | 2.19 |
| 2021-09 | 0 | 1.97 |
| 2021-10 | 1 | 2.18 |
| 2021-11 | 0 | 2.13 |
| 2021-12 | 2 | 2.6 |
| 2022-01 | 0 | 2.65 |
| 2022-02 | 4 | 2.35 |
| 2022-03 | 0 | 2.51 |
| 2022-04 | 1 | 2.48 |
| 2022-05 | 5 | 2.13 |
| 2022-06 | 3 | 2.24 |
| 2022-07 | 0 | 2.2 |
| 2022-08 | 4 | 2.27 |
| 2022-09 | 1 | 2.04 |
| 2022-10 | 0 | 2.12 |
| 2022-11 | 2 | 2.16 |
| 2022-12 | 0 | 2.1 |
| 2023-01 | 0 | 1.85 |
| 2023-02 | 2 | 2.06 |
| 2023-03 | 2 | 2.05 |
| 2023-04 | 2 | 2.22 |
| 2023-05 | 3 | 2.12 |
| 2023-06 | 3 | 2.32 |
| 2023-07 | 3 | 2.11 |
| 2023-08 | 1 | 1.76 |
| 2023-09 | 2 | 1.59 |
| 2023-10 | 4 | 1.64 |
| 2023-11 | 3 | 1.69 |
| 2023-12 | 1 | 1.46 |
| 2024-01 | 1 | 1.9 |
| 2024-02 | 2 | 1.89 |
| 2024-03 | 3 | 1.73 |
| 2024-04 | 4 | 1.87 |
| 2024-05 | 2 | 1.72 |
| 2024-06 | 3 | 1.89 |
| 2024-07 | 5 | 1.63 |
| 2024-08 | 0 | 1.73 |
| 2024-09 | 2 | 1.74 |
| 2024-10 | 3 | 1.73 |
| 2024-11 | 4 | 1.64 |
| 2024-12 | 1 | 1.67 |
| 2025-01 | 1 | 1.74 |
| 2025-02 | 1 | 1.65 |
| 2025-03 | 3 | 1.94 |
| 2025-04 | 2 | 1.73 |
| 2025-05 | 0 | 1.83 |
| 2025-06 | 1 | 1.96 |
| 2025-07 | 3 | 1.8 |
| 2025-08 | 3 | 1.61 |
| 2025-09 | 4 | 1.52 |
| 2025-10 | 2 | 1.69 |
| 2025-11 | 2 | 1.74 |
| 2025-12 | 2 | 2.19 |
| 2026-01 | 1 | 1.93 |
| 2026-02 | 1 | 1.85 |
| 2026-03 | 1 | 1.8 |
| 2026-04 | 1 | 1.74 |
| 2026-05 | 4 | 1.8 |
| 2026-06 | 4 | 1.8 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K120121 — cited as predicate by K152754, K172502, K173411, K193373, K210533, K213459, K231445, K252404
K193373 — cites (transitively): K080642 (d1), K113069 (d1), K113121 (d1), K120121 (d1), K131353 (d1), K132239 (d1), K152754 (d1) — cited as predicate by K212737, K213856, K214001, K233148, K241043, K242253, K243643, K252404, K261683
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC
Nothing in the loaded window.