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Terminated

Arthrocare 3mm ParaFix Anchor, single strand of Magnum Wire,Part Number: 22-5010, Axya Medical, Inc., Beverly, MA 01915

FDA Recall Z-0348-2008 · Posted 2007-12-08

Recalling FirmAxya Medical
Recall StatusTerminated
Product CodeMBI
Date Initiated2007-09-27
Date Terminated2012-06-21
Product Quantity338 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.

K060970AXYALOOP NONABSORBABLE BONE ANCHORAxya Medical, Inc. · 2006-07-05K052491AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHORAxya Medical, Inc. · 2005-10-07K051983MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHORAxya Medical, Inc. · 2005-08-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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