Mac Pin Non-Cannulated Screw, 6.5 x 60mm
FDA Recall Z-0325-2018 · Posted None
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Recalling FirmAmendia, Inc
Recall StatusTerminated
Product CodeNKB
Date Initiated2017-07-07
Date Terminated2019-10-15
Product Quantity41 screws
Reason for Recall
Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
Firm Action
Customers were sent recall notification letters on 07/07/2017. Instructions included to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia, and to complete and return the questionnaire. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.
Root Cause
Process control
Distribution Pattern
Distribution to Georgia, USA.
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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