Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0559-03

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

Zimmer Spine, Inc. / initiated 2003-01-17 / Terminated

Sulzer Spine-Tech began a recall of Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number... on . The reason FDA records is "With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0559-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer Spine, Inc.
Product
Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001.
Product code
LXH Orthopedic Manual Surgical Instrument
Reason for recall
With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip.
FDA root cause
Other
Action
The firm sent a letter, dated January 17, 2003, which requested that the consignees return the product.
Quantity in commerce
14 instruments
Distribution
The instruments to be recalled are at 2 consignees in California and Mississippi. 21 units are with the firm''s sales representatives.
Product codes and lots
Lot numbers P010900 and P010957