Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
FDA Recall Z-2059-2015 · Posted 2015-07-10
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Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeMNH
Date Initiated2009-03-06
Date Terminated2015-07-14
Product Quantity749 devices
Reason for Recall
Incorrect thread form on the screw.
Firm Action
Consignees were notified with a Product Recall Notice on 03/06/2009 that all screws must be checked to ensure that any discrepant products to be removed from the field.
Root Cause
Device Design
Distribution Pattern
Distributed in the states of FL, GA, IL, NY, TX, and WA.
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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