Stryker Howmedica Osteonics Corp.: Medical Device Recall in 2015 - (Recall #: Z-1043-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 15, 2014

Date Posted: February 11, 2015

Recall Number: Z-1043-2015

Event ID: 70100

Reason for Recall:

Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.

Status: Terminated

Product Quantity: seven units

Code Information:

510K 983382 Lot code 49073501

Distribution Pattern:

Nationwide Distribution including NY, OH, PA, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated