Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1487-2017Class II

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

Crossroads Extremity Systems LLC / initiated 2017-02-16 / Terminated / root cause: labeling and UDI

Crossroads Extremity Systems Llc began a recall of MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R on . FDA classified it as Class II and gives the reason as "Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1487-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Crossroads Extremity Systems LLC
Product
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Product code
JDR Staple, Fixation, Bone
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.
Root cause tag
labeling and UDI
FDA root cause
Labeling mix-ups
Action
The firm notified their distributors by email on 02/16-17/2017. The distributors were asked to return the unused lot #101866. The firm also contacted the implanting surgeons either by visit or telephone about the potential for an incorrect size of the implant and asked if there were any adverse events.
Quantity in commerce
20 units
Distribution
Al, FL, IN, Il, NE, TX, NM, CO, AZ
Product codes and lots
Lot Number 101868

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1487-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1487-2017Class IITerminatedVoluntary: Firm initiated