Arthrocare 6.5 mm ParaSorb, Preloaded with 2 MagnumWire sutures (1 white/1 co-braid) with needle Part Number:22-5065N, Axya Medical, Inc., Beverly, MA 01915
FDA Recall Z-0355-2008 · Posted 2007-12-08
Recalling FirmAxya Medical
Recall StatusTerminated
Product CodeMBI
Date Initiated2007-09-27
Date Terminated2012-06-21
Product Quantity361 units
Reason for Recall
Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
Firm Action
Axya Medical notified customers by letter, Urgent-Product Recall, dated 9/25/07 , via UPS . Users are requested to return product and complete the reply form.
Root Cause
Package design/selection
Distribution Pattern
Nationwide
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.