Recall Z-1487-2017— Crossroads Extremity Systems Llc

Name: FDA recall Z-1487-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-16

Class II · Terminated

Class II FDA medical device recall by Crossroads Extremity Systems Llc, initiated 2017-02-16, terminated 2017-04-27. It names one FDA 510(k) clearance: K142727. Product: MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.. Reason: Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm..

Recalling firm: Crossroads Extremity Systems Llc
Classification: Class II
Status: Terminated
Initiated: 2017-02-16
Terminated: 2017-04-27
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K142727 — CrossCLIP Implant SystemOrthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems·cleared 2014-10-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.

Reason for recall

Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.

Data sourced from openFDA. This site is unofficial and independent of the FDA.