Medical device recalls Moderate risk

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

Recall date
January 23, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0539-2018
FDA classification
Class II
Brand / firm
Implant Direct Sybron Manufacturing, LLC
Sold / distributed
CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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