Print-ready dossier — use your browser's print dialog to save as PDF.
Recap Hip System
Model US157356 · Biomet Orthopedics, LLC · DI 00880304684607
KXA — Prosthesis, Hip, Femoral, Resurfacing · Class II · 21 CFR 888.3400
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-0523-2020
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-03
0
2
2019-07
0
3
2019-09
0
6
2019-12
0
1
2020-02
0
3
2020-07
0
2.5
2020-08
0
2
2020-10
0
3
2020-11
0
3
2020-12
0
3
2021-02
0
3
2021-04
0
2
2021-05
0
3
2021-08
0
3
2021-09
0
3
2022-02
0
3
2022-05
0
3.5
2022-10
0
4.5
2024-04
0
3
2026-06
0
2
This device (reports/month)Average device in KXA (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Biomet Orthopedics, LLC