FDA Device

Meridian PA Femoral Stem

Hazard

The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.

What You Should Do

Remedy

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.

Products

Meridian PA Femoral Stem
Brand
Stryker Howmedica Osteonics Corp.
UPC
Catalog No --Description -- # of Lots: 6261-0-001, Meridian PA Hip Stem #00/9, 25 lots; 6261-0-002, Meridian PA Hip Stem #00/10, 26 lots; 6261-0-003, Meridian PA Hip Stem #1/11MM, 107 lots; 6261-0-004, Meridian PA Hip Stem #2/10MM, 16 lots; 6261-0-005, Meridian PA Hip Stem #2/12MM, 109 lots; 6261-0-006, Meridian PA Hip Stem #3/11MM 150 lots; 6261-0-007, Meridian PA Hip Stem #3/13MM, 256 lots; 6261-0-008, Meridian PA Hip Stem #4/12MM, 115 lots; 6261-0-009, Meridian PA Hip Stem #4/14MM, 194 lots; 6261-0-010, Meridian PA Hip Stem #5/13MM, 139 lots; 6261-0-011, Meridian PA Hip Stem #5/15MM, 104 lots; 6261-0-012, Meridian PA Hip Stem #6/14MM, 96 lots; 6261-0-013, Meridian PA Hip Stem, #6/16MM, 73 lots; 6261-0-014, Meridian PA Hip Stem, #7/15MM, 21 lots; 6261-0-015, Meridian PA Hip Stem, #7/17MM, 25 lots; 6261-0-016, Meridian PA Hip Stem, #8/16, 16 lots; 6261-0-017, Meridian PA Hip Stem, #8/18, 15 lots;

Units Affected

1936 units