Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
FDA Recall Z-0539-2018 · Posted None
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Recalling FirmImplant Direct Sybron Manufacturing, LLC
Recall StatusTerminated
Product CodeNHA
Date Initiated2018-01-23
Date Terminated2018-08-09
Product Quantity55 units
Reason for Recall
InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
Firm Action
The firm initiated their recall on 01/23/2018 by letter. the recall notices requested the following actions by the distributors:
"1. Please review your inventory for the affected product.
2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, within 48 hours.
3. If you are an authorized Implant Direct Sybron Manufacturing distributor, we request that you identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of this notification in order to provide the customers with replacement product."
The letter disseminated to the physician requested the following actions:
"1. Please review your inventory for the affected product.
2. Please complete and return the Acknowledgement and Recall Return Form with the affected product, if available, within 48 hours."
Root Cause
Process control
Distribution Pattern
CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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