105 results
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24ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.1 + PKA 3.0.2 + MGO 1.2.2 Application Part Number: 700001590414
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0 + TKA 1.0.1 + THA 4.0.0.1 + PKA 3.0.2 Application Part Number: 700001590415
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software:TKA 2.0.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1. Software: TKA 2.0.it.1+TKA 1.0.1.it.1+PKA3.0.2.it. Application Part Number: 700002190743-01
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.es.1 + PKA 3.0.2.es.1 + THA 4.0. Application Part Number: 700002190743-05
FDA Recall
Open, Classified
·Stryker Orthopaedics·Product code OLO·April 15, 2024
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code JDG·October 15, 2021
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code JDG·October 15, 2021
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code HSX·March 10, 2023
Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.
FDA Recall
Open, Classified
·Stryker Howmedica Osteonics Corp.·Product code MEH·April 30, 2012
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024
X3 TRIATHLON CS INSERT NO 3 10 MM
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024
X3 TRIATHLON CS INSERT NO 6 11 MM
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024
X3 TRIATHLON CS INSERT NO 7 9 MM
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024
NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024
X3 TRIATHLON CS INSERT NO 6 10 MM
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code MBH·February 6, 2024
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Recall
Open, Classified
·Howmedica Osteonics Corp.·Product code OLO·August 7, 2024