BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
FDA Recall Z-0466-2007 · Posted 2007-01-09
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Recalling FirmIntegra LifeSciences Corp.
Recall StatusTerminated
Product CodeHTW
Date Initiated2006-11-10
Date Terminated2008-04-16
Product Quantity107 in US.
Reason for Recall
Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.
Firm Action
An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.
Root Cause
Other
Distribution Pattern
Nationwide to distributors, hospitals and Integra Sales Reps.
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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