—#64300

Product

Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 25 mm, P/N 7211122, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810

FDA product code: HWC — Screw, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051310
Affected lot / code info: All lots

Why it was recalled

Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

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.

Timeline

Recall initiated: 2007-08-21
Posted by FDA: 2008-03-19
Terminated: 2012-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64300. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.