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Terminated

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

FDA Recall Z-1487-2017 · Posted 2017-03-20

Recalling FirmCrossroads Extremity Systems Llc
Recall StatusTerminated
Product CodeJDR
Date Initiated2017-02-16
Date Terminated2017-04-27
Product Quantity20 units

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.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Al, FL, IN, Il, NE, TX, NM, CO, AZ

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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