Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001.
FDA Recall Z-0559-03 · Posted 2003-02-21
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Recalling FirmSulzer Spine-Tech
Recall StatusTerminated
Product CodeLXH
Date Initiated2003-01-17
Date Terminated2003-05-28
Product Quantity14 instruments
Reason for Recall
With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip.
Firm Action
The firm sent a letter, dated January 17, 2003, which requested that the consignees return the product.
Root Cause
Other
Distribution Pattern
The instruments to be recalled are at 2 consignees in California and Mississippi. 21 units are with the firm''s sales representatives.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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