notyard
09-04-2008, 09:55 AM
FDA class III recall:
PRODUCT
Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, “Acu-Loc Distal Radius Plate, Standard, Left… PL-DR50L W48003, Recall # Z-2153-2008
CODE
Lot: W4800; Expiration date: 2012-02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Acumed LLC, Hillsboro, OR, by letter on June 29, 2007.
Manufacturer: Specialized Medical Devices, Lancaster, PA. Firm initiated recall is complete.
REASON
Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
VOLUME OF PRODUCT IN COMMERCE
51 plates
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, “Acu-Loc Distal Radius Plate, Standard, Left… PL-DR50L W48003, Recall # Z-2153-2008
CODE
Lot: W4800; Expiration date: 2012-02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Acumed LLC, Hillsboro, OR, by letter on June 29, 2007.
Manufacturer: Specialized Medical Devices, Lancaster, PA. Firm initiated recall is complete.
REASON
Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
VOLUME OF PRODUCT IN COMMERCE
51 plates
DISTRIBUTION
Nationwide and Internationally