U.S. CALAXO SCREW RECALL

CALAXO Bioabsorbable Interference Screw
RECALLED PRODUCT:

  • a) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm, P/N 7211109, Ligament Screw, Recall # Z-0593-2008
  • b) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 25 mm, P/N 7211110, Ligament Screw, Recall # Z-0594-2008;
  • c) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 6 mm x 25 mm, P/N 7211111, Ligament Screw, Recall # Z-0595-2008;
  • d) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 20 mm, P/N 7211112, Ligament Screw, Recall # Z-0596-2008
  • e) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm, P/N 7211113, Ligament Screw, Recall # Z-0597-2008;
  • f) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 7 mm x 25 mm, P/N 7211114, Ligament Screw, Recall # Z-0598-2008
  • g) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 30 mm, P/N 7211115, Ligament Screw, Recall # Z-0599-2008;
  • h) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 25 mm, P/N 7211116, Ligament Screw, Recall # Z-0600-2008;
  • i) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 30 mm, P/N 7211117, Ligament Screw, Recall # Z-0601-2008;
  • j) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 35 mm, P/N 7211118, Ligament Screw, Recall # Z-0602-2008;
  • k) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 25 mm, P/N 7211119, Ligament Screw, Recall # Z-0603-2008;
  • l) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 30 mm, P/N 7211120, Ligament Screw, Recall # Z-0604-2008;
  • m) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 35 mm, P/N 7211121, Ligament Screw, Recall # Z-0605-2008;
  • n) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 25 mm, P/N 7211122, Ligament Screw, Recall # Z-0606-2008;
  • o) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 30 mm, P/N 7211123, Ligament Screw, Recall # Z-0607-2008;
  • p) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 35 mm, P/N 7211124, Ligament Screw, Recall # Z-0608-2008;
  • q) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 30 mm, P/N 7211125, Ligament Screw, Recall # Z-0609-2008;
  • r) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 35 mm, P/N 7211126, Ligament Screw, Recall # Z-0610-2008;
  • s) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 12 mm x 35 mm, P/N 7211127, Ligament Screw, Recall # Z-0611-2008;
  • t) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 20 mm, P/N 72201069, Ligament Screw, Recall # Z-0612-2008;
  • u) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 20 mm, P/N 72201070, Ligament Screw, Recall # Z-0613-2008;
  • v) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 20 mm, P/N 72201071, Ligament Screw, Recall # Z-0614-2008;
  • w) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 25 mm, P/N 72201072, Ligament Screw, Recall # Z-0615-2008;
  • x) Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 8 mm x 25 mm, P/N 72201073, Ligament Screw, Recall # Z-0616-2008

    CODE
    All lots

    RECALLING FIRM/MANUFACTURERM Recalling Firm: Smith & Nephew, Inc., Endoscopy Division, Andover, MA, by letter on August 21 and August 23, 2007.
    Manufacturer: Smith & Nephew, Inc., Endoscopy Division, Mansfield, MA. Firm initiated recall is ongoing.

    REASON

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

    VOLUME OF PRODUCT IN COMMERCE

    68,285 units

    DISTRIBUTION
    Nationwide and Internationally


    Past Notices:

    SMITH & NEPHEW INC. ENDOSCOPY DIV 9X30MM CALAXO SCREW

    Model Number 7211120
    Device Problem Device breakage
    Event Date 04/19/2006
    Event Type Malfunction Patient Outcome Other;
    Event Description
    Sales rep reports that one of his customers experienced two screws breaking during insertion. The surgeon used an endobutton on the femoral side and a 9x30mm calaxo screw on the tibial side. The surgeon drilled a tunnel of 9mm. He created a notch with a rongeur, made two turns and the screw cracked and was removed. The surgeon made a bigger notch and used another 9x30mm calaxo screw and it also cracked after a couple of turns. It was removed and replaced with a third same size screw and it cracked. The screw was removed and replaced it with an arthrex bio screw without any problems. Sales rep. Said this dr already used 10 calaxo screws with great success. It was confirmed that the surgeon was using a soft tissue allograft and drilled a 9mm tunnel. A dealy of less than fifteen minutes resulted. No pt injury or complications took place.

    Manufacturer Narrative
    Device has not been returned for eval therefore, no determination could be made for the reported device failure.
The device has been recalled in the UK.

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