FDA Device

Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.

Hazard

Product mix-up. 16mm stem in a 18mm package.

What You Should Do

Remedy

Branches and agents were notified via letter on 12/2/2002. Hospitals were notified on 12/2/2002 via FedEx to OR Supervisors.

Products

Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.
Brand
Stryker Howmedica Osteonics
UPC
Catalog No. 6013-1216 -- Lot Code: 37778302; Catalog No. 6013-1218 -- Lot Code: 37778401.

Units Affected

6