Devices

Device Recall Stryker Orthopedics

Model / Serial
510K 983382 Lot code 49073501
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including NY, OH, PA, and TX.
Product Description
Trident PSL HA Solid Back 50 mm || Includes Dome Hole Plug || Ref 540-11-50E || Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.
Manufacturer
Stryker Howmedica Osteonics Corp.
1 Event
- Recall of Device Recall Stryker Orthopedics

Manufacturer

Stryker Howmedica Osteonics Corp.

Manufacturer Address
Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
Manufacturer Parent Company (2017)
Stryker
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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