Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
Corin
Class I - Dangerous
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
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Implants & Prosthetics
🏥 Medical Devices • 4,540 recalls
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Class I - Dangerous
Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
DePuy Orthopaedics
Class I - Dangerous
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
DeRoyal Pacemaker Tray Pgybk, REF 89-6360.06
DeRoyal Industries
Class I - Dangerous
DeRoyal manufactured certain lots of surgical procedure pack products using Hospira Pfizer 1% Lidocaine which was subsequently recalled due to mislabeling; the product is 0.5% Bupivacaine
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Mislabeled product labeling references incorrect length or height, or length and height for specific Lots, Sizes 10x22x14mm, 10x28x14mm, 10x22x15mm
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Signature Orthopedics Pty Limited
Class I - Dangerous
Product mislabeled, with the incorrect product inside the package.
Class I - Dangerous
Not manufactured to specification
Class I - Dangerous
Not manufactured to specification
Class I - Dangerous
Not manufactured to specification
Class I - Dangerous
Not manufactured to specification
Class I - Dangerous
Not manufactured to specification
VICI VENOUS STENT System Product Usage: is intended for the treatment of obstructions and occlusions in the venous vasculature.
Boston Scientific
Class I - Dangerous
The firm has received reports of stent migration after implantation
the firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8 pin. Over time, the shorter pin may not engage in either the upper or lower body, causing the cord to come loose or slip which could result in the loss of suspension.
Class I - Dangerous
The Gore post market surveillance team received a complaint that a GORE¿ VIABIL¿ Biliary Endoprosthesis appeared shorter than the labeled length.
Class I - Dangerous
The firm has received reports of stent migration after implantation