Events

Rappel de Device Recall Stryker Recon, Radial Implant, Standard Stem

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 Stryker Howmedica Osteonics Corp..

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
    71676
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2429-2015
  • Date de mise en oeuvre de l'événement
    2015-06-24
  • Date de publication de l'événement
    2015-08-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-04-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138752
  • 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
    Prosthesis, elbow, semi-constrained, cemented - Product Code JDB
  • Cause
    Stryker is recalling rhead, uhead, sigmoid notch, remotion, radio capitellum because packaging integrity (sterile barrier) of the packaging type kit i may potentially be compromised by transportation.
  • Action
    Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.

Device

Device Recall Stryker Recon, Radial Implant, Standard Stem
  • Modèle / numéro de série
    Part Number: RCN-S1 (#1 Bipolar Stem Implant - Sterile packed) - Lot #'s 18566, 18567, 18568, 18697, 18837, 22297901, 22297902, 22848901, 19099-S2, 19101-S2, 19684-S2, 19685-S2, 19716-S2, 19769-S2, 19803-S2, 19846-S2, 19918-S2, 19919-S2 and 19982-S2; Part Number: RCN-S2 (#2 Bipolar Stem Implant - Sterile packed) - Lot #'s 18295, 18753, 18839, 22098402, 22298001, 22298002, 22614201, 22614202, 22849101, 23068301, 19664-S2, 19718-S2, 19719-S2, 19770-S2, 19771-S2, 19772-S2, 19805-S2, 19847-S2, 19848-S2, 19849-S2, 19850-S2 and 19921-S2; Part Number: RCN-S3 (#3 Bipolar Stem Implant - Sterile packed) - Lot #'s 18296, 18754, 22298101, 22298102, 22614401, 22614402, 22849301, 23068501, 23068502, 23479701, 19665-S2, 19720-S2, 19721-S2, 19722-S2, 19774-S2, 19775-S2, 19776-S2, 19806-S2, 19852-S2, 19853-S2 and R237901; Part Number: RCN-S4 (#4 Bipolar Stem Implant - Sterile packed) - Lot #'s 18885, 18886, 22298201, 22298202, 22614501, 22614502, 22849501, 23068601, 23479901, 19666-S2, 19724-S2, 19725-S2, 19777-S2, 19808-S2, 19855-S2, 19856-S2, 19922-S2, 19988-S2 and R23479901  Part Number: RHA-S1 (Radial Stem Implant #1 - Sterile packed) - Lot #'s 18374, 18387, 18500, 18574, 18705, 18706, 18845, 18846, 18847, 22613001, 22850001, 23069001, 19111-S2, 19112-S2, 19726-S2, 19778-S2 and 19857-S2; Part Number: RHA-S2 (Radial Stem Implant #2 - Sterile packed) - Lot #'s 22098802, 22279401, 22279402, 22613201, 22850201, 23069201, 23493402, 109667-S2, 19780-S2 19781-S2, 19810-S2, 19859-S2, 19860-S2, 19861-S2, 19923-S2 and R23493402;  Part Number: RHA-S3 (Radial Stem Implant #3 - Sterile packed) - Lot #'s 18855, 22098902, 22279501, 22279502, 22613401, 22613402, 22850401, 23069401, 23226201, 23490201, 19687-S2, 19727-S2, 19728-S2, 19729-S2, 19783-S2, 19811-S2, 19812-S2, 19862-S2, 19863-S2, 19924-S2, 19925-S2 and R23490201;  Part Number: RHA-S4 (Radial Stem Implant #4 - Sterile packed) - Lot #'s 18378, 22279601, 22613601, 22613602, 22850601, 23069501, 23226301, 23491501, 19668-S2, 19784-S2, 19814-S2, 19864-S2, 19926-S2, 19927-S2 and R23491501;  Part Number: WA/C-L (Wrist Carpal Implant Large) - Lot #'s 23689901, 23946601, 23946602, 23946603, 24056601 and 19064-S2;  Part Number: WA/C-M (Wrist Carpal Implant Medium) - Lot #'s 22296901, 22296902, 22595501, 22595502, 22758401, 22758402, 23041201, 23216201, 23689801, 23689802, 23689803, 23946801, 23946802, 23946803, 24056701, 24056702 and 24056703;  Part Number: WA/C-S (Wrist Carpal Implant Small) - Lot #'s 22297001, 22297002, 22431101, 22595601, 225965602, 22758501, 22758502, 23041301, 23689701, 23689702, 23689703, 23946701, 23946702, 23946703, 24056801, 24056802 and 24056803;  Part Number: WA/R-LL (Wrist Left Radial Implant Large) - Lot #'s 18872, 23946901, 23946902, 23946903, 24056901, 19061-S2, 19605-S2, 19828-S2, 19829-S2, 19955-S2, R19605-S2, R19828-S2 and R19829-S2;  Part Number: WA/R-LM (Wrist Left Radial Implant Medium) - Lot #'s 22595701, 22758601, 22758602, 23041401, 23690401, 23690401, 23690402, 23690403, 24057001, 19062-S2, R23690401, R23690402 and R23690403;  Part Number: WA/R-LS (Wrist Left Radial Implant Small) - Lot #'s 22758701, 22758702, 23041501, 23216301, 23690501, 23690502, 24057101, 24057102, R23690501 and R23690502;  Part Number: WA/R-LXS (Distal Radial Comp X-Small, Left, Sterile) - Lot #'s 18794, 18873, 22758801, 22758802 and 23041601;  Part Number: WA/R-RL (Wrist Right Radial Implant Large) - Lot #'s 18795, 23690001, 23690002, 23690003, 24057201, R23690001, R23690002 and R23690003;  Part Number: WA/R-RM (Wrist Right Radial Implant Medium) - Lot #'s 15892, 22297101, 22595801, 22758901, 22758902, 23041701, 23261401, 23690101, 23690102, 23690103, 23947101, 23947102, 24057301, R23690101 and R23690102;  Part Number: WA/R-Rs (Wrist Right Radial Implant Small) - Lot #'s 22297201, 22595901, 22595901, 22595902, 22759001, 22759002, 23041801, 23261501, 23690201, 23690202, 23690203, 23947001, 23947002, 23947003, 23947004, 24057401, 19073-S2, R23690201 and R23690202;  Part Number: WA/R-RXS (Distal Radial Comp X-Small, Right, Sterile) - Lot #'s 18796, 18874, 22596001, 22759101, 22759102, 23041901, 23690301, 23690302, 23690303, 23947201, 24057501, R23690301, R23690302 and R23690303.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution.
  • Description du dispositif
    Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the proximal end of the radius.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA