MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm
FDA Recall Z-0212-2020 · Posted None
Recalling FirmCrossRoads Extremity Systems, LLC
Recall StatusTerminated
Product CodeHWC
Date Initiated2019-09-19
Date Terminated2021-12-02
Product Quantity36 screws
Reason for Recall
Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.
Firm Action
CrossRoads Extremity Systems notified customers on about 09/19/2019 via email. The email informed customers that pack-out potentially includes a 3.0mm x 30mm screw instead of 3.0 x 28mm screw. Instructions included to return all affected screws to CrossRoads Extremity Solutions immediately with provided label and return materials authorization.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide distribution to AK, CA, FL, GA, IL, MA, MN, NC, NJ, OK, OR, 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.