| Class 2 Device Recall CALAXO | |
Date Initiated by Firm | August 21, 2007 |
Date Posted | March 19, 2008 |
Recall Status1 |
Terminated 3 on May 09, 2012 |
Recall Number | Z-0614-2008 |
Recall Event ID |
44704 |
510(K)Number | K051310 |
Product Classification |
Ligament Screw - Product Code HWC
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Product | Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 20 mm,
P/N 72201071, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 |
Code Information |
All lots |
Recalling Firm/ Manufacturer |
Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Drive Andover MA 01810-1031
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For Additional Information Contact | SAME 978-749-1073 |
Manufacturer Reason for Recall | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Smith & Nephew issued an Urgent Product Recall letter via Federal Express to User Facilities, Sales Reps and Distributors on 8/21/07. A second letter was issued on 8/23/07 to correct two errors in model numbers listed in the original letter. Letter issued by FedEx and/or email to OUS contacts. |
Quantity in Commerce | 278 units |
Distribution | Worldwide Distribution - USA, Austria. Belgium, Germany, Denmark, Spain, Finland, France, England, Italy, Portugal, Netherlands, Norway, New Zealand, Sweden, Turkey, Switzerland,
China, Hong Kong, Malaysia, Taiwan, Singapore, Thailand, Australia, Canada, Mexico, Colombia, South Africa, Dubai, Venezuela, and Chile. |
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 = HWC
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