TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
FDA Recall Z-2541-2016 · Posted None
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Recalling FirmTYRX Inc.
Recall StatusTerminated
Product CodeFTL
Date Initiated2016-06-29
Date Terminated2017-12-12
Product Quantity194 units
Reason for Recall
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Firm Action
Medtronic sent an Urgent Medical Device Recall letter dated June 2016 to affected customers. The letter identified the affected product problem and actions to be taken. Customers are asked to immediately remove and quarantine all unused product that remains in inventory, return unused product to Medtronic and contacted the local Medtronic representative or Customer Service at 800-848-9300 to assist with the return and credit of unused product. Medtronic will provide credit for all non-expired, unused product. The customer should complete the attached Customer Confirmation Certificate and email to [email protected] or fax to Medtronic at 651-367-0612 Attention Customer Focused Quality.
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution
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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