Z-0212-2020Class II

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

Name: Z-0212-2020 MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm
Creator: CrossRoads Extremity Systems, LLC
Published: 2019-09-19
License: https://open.fda.gov/license/

Crossroads Extremity Systems LLC / initiated 2019-09-19 / Terminated / root cause: labeling and UDI

FDA source

CrossRoads Extremity Systems, LLC began a recall of MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm on 2019-09-19. FDA classified it as Class II and gives the reason as "Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0212-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-19
Posted: 2019-10-24
Terminated: 2021-12-02
Recalling firm: Crossroads Extremity Systems LLC
Product: MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm
Product code: HWC Screw, Fixation, Bone
Reason for recall: Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 36 screws
Distribution: Nationwide distribution to AK, CA, FL, GA, IL, MA, MN, NC, NJ, OK, OR, WA.
Product codes and lots: Part Number: 15PL-3028, Lot Number: 500750

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0212-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0212-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-24

Product code HWC

K173710Class IIMotoBAND CP Implant SystemCrossroads Extremity Systems, LLC / cleared 2018-02-12

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)