Class I - Dangerous
The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique
Class I - Dangerous
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
Class I - Dangerous
The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
KNEE SCOPE Procedure tray Catalog Number: COKN48L
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
Class I - Dangerous
Due to incorrect milled titanium abutment being packaged and labeled.
CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.
ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B
American Contract Systems
Class I - Dangerous
Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding component exceeded the residual limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.