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Terminated

Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 6 mm x 25 mm, P/N 7211111, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810

FDA Recall Z-0595-2008 · Posted 2008-03-19

Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeHWC
Date Initiated2007-08-21
Date Terminated2012-05-09
Product Quantity600 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.

K051310PLC SCREWSmith & Nephew, Inc. · 2005-07-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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