FDAClass IIFebruary 14, 2018

Implant Direct recall

Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform

Why was Implant Direct recalled?

InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 104203

Product
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Recalling firm
Implant Direct Sybron Manufacturing, LLC
Quantity
55 units
Distribution
CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands
Recall date
February 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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