notyard
09-04-2008, 09:36 AM
FDA class II recall:
PRODUCT
3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... ". Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System) for the multi-planar fixation. The screws are sold individually to support the Polarus Locking Humeral Rod systems in the field, Recall # Z-2155-2008
CODE
Lot: W24552; Expiration date: 2010-05
RECALLING FIRM/MANUFACTURER
Acumed LLC, Hillsboro, OR, by fax or e-mail on December 27, 2005. Firm initiated recall is complete.
REASON
Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 5mm cortical screw.
VOLUME OF PRODUCT IN COMMERCE
112 screws
DISTRIBUTION
Nationwide and Internationally
PRODUCT
3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... ". Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System) for the multi-planar fixation. The screws are sold individually to support the Polarus Locking Humeral Rod systems in the field, Recall # Z-2155-2008
CODE
Lot: W24552; Expiration date: 2010-05
RECALLING FIRM/MANUFACTURER
Acumed LLC, Hillsboro, OR, by fax or e-mail on December 27, 2005. Firm initiated recall is complete.
REASON
Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 5mm cortical screw.
VOLUME OF PRODUCT IN COMMERCE
112 screws
DISTRIBUTION
Nationwide and Internationally