23 results
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22ms
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Sources: EU EUDAMED, US FDA
OMNISORB II, NONWOVEN SPONGE, STERILE AND NON
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INTRADISCAL THERAPY NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·May 5, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND COMPANY BD BIOSCIENCES·Product code GKZ·May 22, 2023
RSP SHOULDER
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWS·January 22, 2013
LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM
FDA Adverse Event
Injury
·ANGIOMED GMBH & CO, MEDIZINTECHNIK·Product code NIP·December 10, 2010
MUSTANG?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·July 14, 2014
PS TIBIAL INSERTS SZ 4, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 14, 2023
PT HYBRID GLEN POST REGENEREX
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·December 30, 2021
CC FEMORAL SZ 3
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 10, 2024
CEMENTED FINNED TIB. TRA SZ 3F/3T
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 19, 2024
SM HYBRID GLENOID BASE 4MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·November 19, 2021
OPTETRAK KNEE SYSTEM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 23, 2024
BD MULTI-CHECK¿
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·July 26, 2023
OPTETRAK KNEE COMPONENTS
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·October 29, 2024
PS TIBIAL INSERTS SZ 2, 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 13, 2025
CC TIBIAL INSERT SZ 4, 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 4, 2024
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Numbers: 200-11-XX, 200-12-XX, 200-13-XX, 200-14-XX, 200-15-XX, 200-16-XX; b. OPTETRAK All-polyethylene PS Tibial Components, with Product Line Numbers: 204-11-XX, 204-12-XX, 204-13-XX, 204-14-XX, 204-15-XX, 204-16-XX; c. OPTETRAK HI-FLEX PS Polyethylene Tibial Inserts, with Product Line Numbers: 244-20-XX, 244-21-XX, 244-22-XX, 244-23-XX, 244-24-XX, 244-25-XX; d. OPTETRAK CR Tibial Inserts, with Product Line Numbers: 200-21-XX, 200-22-XX, 200-23-XX, 200-24-XX, 200-25-XX, 200-26-XX, 200-50-XX, 200-51-XX; e. OPTETRAK CR Tibial Slope + Insert, with Product Line Numbers: 200-56-XX, 200-57-XX, 200-61-XX, 200-62-XX, 200-63-XX, 200-64-XX, 200-65-XX; f. OPTETRAK CR Tibial Slope ++ Insert, with Product Line Numbers: 200-57-XX, 200-71-XX, 200-72-XX, 200-73-XX, 200-74-XX, 200-75-XX; g. OPTETRAK PS Tibial Inserts, with Product Line Numbers: 204-21-XX, 204-22-XX 204-23-XX, 204-24-XX, 204-25-XX, 204-26-XX, 204-50-XX, 204-51-XX; h. OPTETRAK "MOMB" Non-Mod Molded Insert, with Product Line Numbers: 204-91-XX, 204-92-XX, 204-93-XX, 204-94-XX, 204-95-XX; i. OPTETRAK CC Tibial Insert, with Product Line Numbers: 208-21-XX, 208-22-XX, 208-23-XX, 208-24-XX, 208-25-XX, 208-51-XX; j. OPTETRAK B-Series PS Tibial Insert, with Product Line Numbers: 224-21-XX, 224-22-XX, 224-23-XX, 224-24-XX. Affected 510(k) numbers include: K932690, K933494, K932776, K011976, K082022, K933610, K030686, K954208, K010434, K033883. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code JWH·August 30, 2021