Biomet UK Ltd.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
3
Inspections
3
Compliance Actions
0

Known Names

biomet uk, biomet u.k

Recent Recalls

NumberClassProductDate
Z-3263-2018Class IIHipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number:August 9, 2018
Z-3264-2018Class IIHipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number:August 9, 2018
Z-3261-2018Class IIHipLOC Hip Fracture Fixation System- Hiploc System 130¿ Plate 38 mm Barrel 4 Hole Plate Item NumberAugust 9, 2018
Z-3262-2018Class IIHipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item NumbeAugust 9, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K200959Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR LabelingJuly 29, 2020
K192683Biolox delta Ceramic Heads, Biolox delta Option Ceramic HeadsFebruary 27, 2020
K133940OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)March 28, 2014