8 results
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54ms
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Sources: EU EUDAMED, US FDA
THEKEN COMPANIES, LLC
FDA registration
THEKEN COMPANIES, LLC·25 products·🇺🇸 United States
INSITU HIP REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·THEKEN COMPANIES, LLC·Product code LPH·December 21, 2018
INSITU HIP SYSTEM
FDA Adverse Event
Injury
·THEKEN COMPANIES, LLC·Product code LPH·November 8, 2018
INSITU HIP SYSTEM
FDA Adverse Event
Injury
·THEKEN COMPANIES LLC·Product code LPH·May 31, 2018
THEKEN
FDA Adverse Event
Malfunction
·THEKEN COMPANIES, LLC·Product code LXH·April 25, 2018
INSITU HIP SYSTEM
FDA Adverse Event
Injury
·THEKEN COMPANIES LLC·Product code LPH·May 31, 2018
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm
FDA Recall
Open, Classified
·Theken Companies LLC·Product code MEH·September 11, 2025
iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm
FDA Enforcement
Class II
·Ongoing·Theken Companies LLC·October 29, 2025