1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company
FDA Recall Z-0808-04 · Posted 2004-07-20
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Recalling FirmSpinal Concepts, Inc
Recall StatusTerminated
Product CodeKWQ
Date Initiated2004-03-01
Date Terminated2007-04-13
Product Quantity25 (1757-1)
Reason for Recall
Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
Firm Action
The firm initiated the recall via telephone on 03/01/2004 to all distributors followed up by recall letter on 03/05/2004.
Root Cause
Other
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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