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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-0344-2008
Recall Event ID 44963
510(K)NumberK051983 K052491 K060970 
Product Classification Bone Anchor - Product Code MBI
ProductAxya Bone Anchor, 5.0 mm Bioabsorbable in Super Kit, Catalog Number: CAT1271, Axya Medical, Inc., Beverly, MA 01915
Code Information Lot Numbers: 203864, 203957, 203973, 204024, 204035, 204111, 204127, 204148, 204177, 204183, 204228, 204238, 204243, 204247, 204248, 204262, 204278, 204291, 204303, 204306, 204307, 204319, 204321, 204342, 204351, 204387, 204417, 204422, 204445, 204460,204461, 204474, 204475, 204478, 204488, 204504, 204512, 204515, 204522, 204566,204568, 204569, 204675, 204688, 204691, 204722, 204723, 204782, 204789, 204796,204842, 204843, 204866, 204894, 204955, 204969, 205000, 205053, 205110 and 205658 
FEI Number 3000718467
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 Commerce329 units
DistributionNationwide
Total Product Life CycleTPLC Device Report
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 = MBI
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