FDA Device

Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001.

Hazard

With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip.

What You Should Do

Remedy

The firm sent a letter, dated January 17, 2003, which requested that the consignees return the product.

Products

Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001.
Brand
Sulzer Spine-Tech
UPC
Lot numbers P010900 and P010957

Units Affected

14 instruments