Biomet U.K., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
26
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1171-2017Class IIOxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product Usage: InstrumentJanuary 5, 2016
Z-1172-2017Class IIOxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product Usage: Instruments fJanuary 5, 2016
Z-1160-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for usJanuary 5, 2016
Z-1153-2017Class IIOxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford January 5, 2016
Z-1168-2017Class IIOxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the OxforJanuary 5, 2016
Z-1162-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage: Instruments for usJanuary 5, 2016
Z-1152-2017Class IIOxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with thJanuary 5, 2016
Z-1167-2017Class IIOxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: Instruments for useJanuary 5, 2016
Z-1165-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System LeftJanuary 5, 2016
Z-1173-2017Class IIOxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product Usage: Instruments January 5, 2016
Z-1158-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for usJanuary 5, 2016
Z-1166-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usage: Instruments for usJanuary 5, 2016
Z-1159-2017Class IIOxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for uJanuary 5, 2016
Z-1170-2017Class IIOxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the OxforJanuary 5, 2016
Z-1161-2017Class IIOxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for useJanuary 5, 2016
Z-1169-2017Class IIOxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the OxforJanuary 5, 2016
Z-1157-2017Class IIOxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for useJanuary 5, 2016
Z-1163-2017Class IIOxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage: Instruments for useJanuary 5, 2016
Z-1155-2017Class IIOxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: InstrumentJanuary 5, 2016
Z-1156-2017Class IIOxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for usJanuary 5, 2016