Mitek Angled Side Effect Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope.
FDA Recall Z-1670-2008 · Posted 2008-09-19
Recalling FirmAscent Healthcare Solutions, Inc.
Recall StatusTerminated
Product CodeHRX
Date Initiated2008-03-11
Date Terminated2012-06-29
Product Quantity4 of 4
Reason for Recall
Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
Firm Action
A recall notification letter titled Voluntary Medical Device Recall was sent to each consignee. If you have questions about this recall on numerous reprocessed devices, contact Moira Barton-Varty at 888-888-3433, ext. 5350 or at [email protected].
Root Cause
Process control
Distribution Pattern
Class II Recall - Nationwide Distribution.
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.