Class I - Dangerous
The devices may be packaged with the wrong reamer size.
Arthrex
28 recalls • • Categories: Implants & Prosthetics, Other Medical Devices, Infusion Pumps, Surgical Instruments
Class I - Dangerous
Products do not meet length and diameter specifications.
Class I - Dangerous
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Class I - Dangerous
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Class I - Dangerous
The color indicator on the proximal end of the shaft of the AR-8770-02 is the incorrect color.
Screws provided in packaging are 5mm shorter than intended
Screws provided in the device package are 6 mm longer than intended.
Class I - Dangerous
There is a potential for blockage of the Hub Attachment Tube.
Devices may generate excessive heat during use.
Potentially lead to anchor breakage during insertion,
There is potential to break during use.
Class I - Dangerous
The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.
Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UFRA, size 1 printed on the patient label inside the box.
Class I - Dangerous
Some eyelets broke from SwiveLock Anchor on insertion.
Class I - Dangerous
Some eyelets broke from SwiveLock Anchor on insertion.
Class I - Dangerous
Some eyelets broke from SwiveLock Anchor on insertion.
Class I - Dangerous
Some eyelets broke from SwiveLock Anchor on insertion.
Class I - Dangerous
Some eyelets broke from SwiveLock Anchor on insertion.
Class I - Dangerous
Some eyelets broke from SwiveLock Anchor on insertion.
Class I - Dangerous
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
Class I - Dangerous
Potential for polystyrene particulate presence.
Class I - Dangerous
Potential for polystyrene particulate presence.
Class I - Dangerous
Potential for polystyrene particulate presence.
Class I - Dangerous
Potential for polystyrene particulate presence.
Class I - Dangerous
Potential for polystyrene particulate presence.
Class I - Dangerous
Potential for polystyrene particulate presence.
Potential for a component contained in the Implant System to be non-sterile.
Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.