AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44.
FDA Recall Z-0916-2007 · Posted 2007-06-09
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Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2006-07-21
Date Terminated2012-05-06
Product Quantity6
Reason for Recall
The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.
Firm Action
The consignees were contacted by fax and email (dated July 21, 2006) to inform them of the recall requesting return of product
Root Cause
Other
Distribution Pattern
World wide-Domestically distributed to one account in Alabama and internationally to Columbia and Australia.
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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