Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 30 mm, P/N 7211125, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810
FDA Recall Z-0609-2008 · Posted 2008-03-19
Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeHWC
Date Initiated2007-08-21
Date Terminated2012-05-09
Product Quantity1990 units
Reason for Recall
Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.