Events

Rappel de Device Recall Synthes Resorbable Fixation Systems Resorbable Taps and Screws

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Synthes (USA).

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    35109
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0792-06
  • Date de mise en oeuvre de l'événement
    2006-03-30
  • Date de publication de l'événement
    2006-04-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-09-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45332
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Plate, Bone - Product Code JEY
  • Cause
    Integrity of outer mylar pouch could be compromised, possibly rendering the exterior of the inner foil pouch unsterile.
  • Action
    Synthes Craniofacial Sales consultants were notified and instructed to immediately notify their accounts concerning this recall. Synthes contacted the customer accounts via phone 3/31/06 through 4/3/06 and subsequently via Certified Mail on 4/3/06.

Device

Device Recall Synthes Resorbable Fixation Systems Resorbable Taps and Screws
  • Modèle / numéro de série
    Product, Catalog #, Lot #, Expiration Date 1.5MM resorbable cortex screw 3MM-sterile, 800.603.10S, 1373642, 07/2009; 1.5MM resorbable cortex screw 3MM-sterile, 800.603.20S, 1372400, 07/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1384887, 08/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.02S, 1393224, 09/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2162367, 10/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2175547, 01/2010; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.04S, 2183488, 02/2010; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.10S, 1371226, 07/2009; 1.5MM resorbable cortex screw 4MM-sterile, 800.604.20S, 1371227, 07/2009; 1.5MM resorbable cortex screw 5MM-sterile, 800.605.10S, 1372687, 07/2009; 1.5MM resorbable cortex screw 6MM-sterile, 800.606.10S, 1373640, 07/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1384577, 08/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.04S, 1387942, 09/2009; 1.5MM resorbable tack 4MM-sterile, 800.614.10S, 1373751, 07/2009; 2.0MM resorbable cortex screw 4MM-sterile, 801.004.10S, 1374122, 07/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2162368, 10/2009; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.04S, 2184323, 02/2010; 2.0MM resorbable cortex screw 6MM-sterile, 801.006.10S, 1374135, 07/2009; 2.5MM resorbable emergency screw 8MM-sterile, 801.048.02S, 1384578, 8/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1384602, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.04S, 1393219, 09/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1372401, 07/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1376216, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile, 805.603.10S, 1377498, 08/2009; 1.5MM rapid resorbable cortex screw 3MM-sterile,  805.603.20S, 1372402, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2169297, 12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.02S, 2180984, 02/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384597, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1384598, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 1384599, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1392087, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 1392088, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 1393230, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 2162401, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163458, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2163459, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2164282, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2167890, 10/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.04S, 2169299, 12/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175554, 01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.04S, 2175801, 01/2010; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370038, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1370040, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1370041, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375932, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1375933, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1376307, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1377501, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1377502, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1380682, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385761, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385763, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1385764, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1385780, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1388207, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1390841, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1392090, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.10S, 1393233, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.10S, 1393234, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1370039, 07/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1376219, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1377503, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1378428, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile,  805.604.20S, 1383881, 08/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1390843, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 1392089, 09/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2167288, 11/2009; 1.5MM rapid resorbable cortex screw 4MM-sterile, 805.604.20S, 2181842, 02/2010; 1.5MM rapid resorbable cortex screw 5MM-sterile,  805.605.04S, 1384604, 08/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 1392091, 09/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.04S, 2167289, 11/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 1374134, 07/2009; 1.5MM rapid resorbable cortex screw 5MM-sterile, 805.605.10S, 2175551, 01/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile,  805.606.02S, 1393239, 09/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.02S, 2181849, 02/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.04S, 2164288, 10/2010; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 1373641, 07/2009; 1.5MM rapid resorbable cortex screw 6MM-sterile, 805.606.10S, 2167291, 11/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile,  805.608.02S, 2171103, 12/2009; 1.5MM rapid resorbable cortex screw 8MM-sterile, 805.608.04S, 2175552, 01/2010; 1.5MM rapid resorbable tack 4MM-sterile, 805.614.04S, 1387950, 09/2009; 1.5MM rapid resorbable tack 4MM-sterile,  805.614.10S, 2165696, 11/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160255, 09/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.04S, 2160256, 09/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1374125, 07/2009; 2.0MM rapid resorbable cortex screw 4MM-sterile, 806.004.10S, 1377504, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile,  806.006.02S, 2167290, 11/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1384596, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388815, 09/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1385773, 08/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile, 806.006.04S, 1388795, 09/2009; 2.0MM rapid resorbable cortex screw 6MM-sterile,  806.006.10S, 1374136, 07/2009; 2.5MM rapid resorbable emergency screw 4MM-sterile, 806.044.02S, 1392093, 09/2009; 2.5MM rapid resorbable emergency screw 6MM-sterile, 806.046.02S, 2163371, 10/2009.
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide and Canada. Distribution to 1 Military/Government account - Tripler Army Medical Center, Honolulu, HI; 1 foreign account - Synthes Canada; and geographical distribution within the United States to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, AND WV.
  • Description du dispositif
    Synthes Resorbable Fixation Systems Resorbable Taps and Screws. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton.
  • Manufacturer
    Synthes (USA)

Manufacturer

Synthes (USA)
  • Adresse du fabricant
    Synthes (USA), 1302 Wrights Lane East, West Chester PA 19380
  • Source
    USFDA