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Recall Observatory FDA recall evidence

Device product

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

Z-0539-2018

January 23, 2018

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
Event
Event 78917
Status
Terminated
Classification
Class II
Quantity
55 units
Official record key
device-enforcement:Z-0539-2018

Official wording

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

Code information: Lot Number 104203

Distribution pattern: CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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