Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0107-06

Meridian ST Femoral Stem

Howmedica Osteonics Corp / initiated 2005-08-24 / Terminated

Stryker Howmedica Osteonics Corp. began a recall of Meridian ST Femoral Stem on . The reason FDA records is "The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0107-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Howmedica Osteonics Corp
Product
Meridian ST Femoral Stem
Product code
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Reason for recall
The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.
FDA root cause
Other
Action
A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.
Quantity in commerce
71 units.
Distribution
nationwide
Product codes and lots
Catalog #---Description -- # of lots: 6265-0-005, Meridian ST Hip Stem #2/12MM, 13 lots; 6265-0-006, Meridian ST Hip Stem #3/11MM, 3 lots; 6265-0-007, Meridian ST Hip Stem #3/13MM, 31 lots; 6265-0-009, Meridian ST Hip Stem, #4/14MM, 4 lots; 6265-0-011, Meridian ST Hip Stem, no # 15 lots; 6265-0-013, Meridian ST Hip Stem #6/16MM, 7 lots