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U.S. Department of Health and Human Services

Class 2 Device Recall Axya

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 Class 2 Device Recall Axyasee related information
Date Initiated by FirmSeptember 27, 2007
Date PostedDecember 08, 2007
Recall Status1 Terminated 3 on June 21, 2012
Recall NumberZ-0331-2008
Recall Event ID 44963
510(K)NumberK051983 K052491 K060970 
ProductAxya Bone Anchor , 3.0 mm Titanium with Nylon Suture Catalog Number: CAT1226, Axya Medical, Inc., Beverly, MA 01915
Code Information Lot Numbers: 203213, 203233, 203335, 203465, 203720, 203736, 204367, 204413, 204695, and 204802 
Recalling Firm/
Manufacturer		 Axya Medical
100 Cummings Ctr Ste 444c
Beverly MA 01915-6132
For Additional Information ContactSAME
978-232-9997 Ext. 647
Manufacturer Reason
for Recall		Sterility Compromised (Package Integrity): Sterility of the device may be compromised due to holes in the sterile packaging
FDA Determined
Cause 2		Package design/selection
ActionAxya 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.
Quantity in Commerce1,008 units
DistributionNationwide
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code =
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