🏥 Medical Devices • 15,203 recalls
Onkos Surgical
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Onkos Surgical
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
Mckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Straumann USA
The referred batch was produced without the laser engraving of 7 mm.
Potential for breach of Tyvek seals.
Mckesson Medical-Surgical Inc. Corporate Office
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Potential for breach of Tyvek seals.
Potential for breach of Tyvek seals.
Onkos Surgical
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Imaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior, inferior, anterior or posterior). This may lead to an inaccurate measurements.
Philips North America
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Cook Incorporated
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Philips North America
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips North America
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Philips North America
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
Cook Incorporated
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.
Smith & Nephew
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.