Date Initiated by Firm | September 27, 2007 |
Date Posted | December 08, 2007 |
Recall Status1 |
Terminated 3 on June 21, 2012 |
Recall Number | Z-0355-2008 |
Recall Event ID |
44963 |
510(K)Number | K051983 K052491 K060970 |
Product Classification |
Sutures - Product Code MBI
|
Product | 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 |
Code Information |
Lot Numbers: 205322 205323 205324 205325 205334 205341 205360 205508 205632 and 205633 |
Recalling Firm/ Manufacturer |
Axya Medical 100 Cummings Ctr Ste 444c Beverly MA 01915-6132
|
For Additional Information Contact | SAME 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 |
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. |
Quantity in Commerce | 361 units |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = MBI
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