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U.S. Department of Health and Human Services

Class 2 Device Recall CALAXO

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  Class 2 Device Recall CALAXO see related information
Date Initiated by Firm August 21, 2007
Date Posted March 19, 2008
Recall Status1 Terminated 3 on May 09, 2012
Recall Number Z-0600-2008
Recall Event ID 44704
510(K)Number K051310  
Product Classification Ligament Screw - Product Code HWC
Product Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 25 mm,
P/N 7211116, 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
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 7805 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
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) Database 510(K)s with Product Code = HWC and Original Applicant = SMITH & NEPHEW, INC.
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