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MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm… recallZ-1487-2017 · Crossroads Extremity Systems Llc · initiated Feb 16, 2017

Class II Terminated All recalls posted in March 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Crossroads Extremity Systems Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-1487-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 16, 2017
Posted by the FDA
Mar 20, 2017
Recalling firm
Crossroads Extremity Systems Llc
Quantity
20 units
Product code
JDR
FDA submissions
K142727
Distribution
Al, FL, IN, Il, NE, TX, NM, CO, AZ

Product description

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

Code information (models, lots, serial numbers)

Lot Number 101868

Other devices under the same FDA submission

12 devices cleared under K142727 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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