Z-0212-2020 Class II Terminated

Recalled by CrossRoads Extremity Systems, LLC — Memphis, TN

FDA device recall Z-0212-2020 was initiated by CrossRoads Extremity Systems, LLC on September 19, 2019 and is designated Class II. Reason for recall: Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw. The recall status is terminated (terminated December 2, 2021). Affected quantity: 36 screws.

Recall Details

Product Type
Devices
Report Date
October 30, 2019
Initiation Date
September 19, 2019
Termination Date
December 2, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36 screws

Product Description

MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm

Reason for Recall

Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.

Distribution Pattern

Nationwide distribution to AK, CA, FL, GA, IL, MA, MN, NC, NJ, OK, OR, WA.

Code Information

Part Number: 15PL-3028, Lot Number: 500750