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Medical Device Recalls
Class 2 Recall
Axya
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Date Recall Initiated |
September 27, 2007
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Date Posted |
December 08, 2007
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Recall Number |
Z-0335-2008
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Product |
Axya Bone Anchor 5.0 mm Titanium with UHMWPE Suture
Catalog Number: CAT1269, Axya Medical, Inc., Beverly, MA 01915
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Code Information |
Lot Numbers:
204680, 204815, 204881, 204895, and 204907
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Recalling Firm/ Manufacturer |
Axya Medical
100 Cummings Ctr Ste 444c
Beverly
, Massachusetts
01915-6132
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For Addition Information Contact |
SAME
978-232-9997 Ext. 647
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Reason For Recall |
Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
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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.
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Quantity in Commerce |
417 units
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Distribution |
Nationwide
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