Recall Z-1043-2015— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-1043-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-15

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2014-12-15, terminated 2016-09-22. It names one FDA 510(k) clearance: K983382. Product: 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.. Reason: 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..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-12-15
Terminated: 2016-09-22
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K983382 — OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEMOsteonics Corp.·cleared 1998-12-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.