Events

Rappel de Device Recall Stryker Impaction Bur Guard

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 Instruments Div. of Stryker Corporation.

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
    50896
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1052-2009
  • Date de mise en oeuvre de l'événement
    2009-01-27
  • Date de publication de l'événement
    2009-03-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-12-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77614
  • 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
    Surgical Instrument Ac-Powered Motor and Accessory - Product Code HWE
  • Cause
    Bur guards were distributed without an expiration date, and if they are used after they have expired it could result in the patient or operating room staff experiencing a burn or laceration.
  • Action
    Customers were notified via a Medical Device Recall Notification letter dated 1/27/09 and instructed to immediately check all stock areas or operating room storage and inspect their bur guards for an expiration date. They were also instructed to quarantine any affected product found, to indicate on the Business Reply Form the quantity of affected product on hand, to destroy any affected product found without an expiration date by breaking off at least 3 of the tabs on the bur guard, then dispose of the affected product in normal trash, and complete and return the business reply form. Customers are to fax the Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2760. Upon receipt of the Business Reply Form, a replacement bur guard(s) will be sent for any affected product destroyed.

Device

Device Recall Stryker Impaction Bur Guard
  • Modèle / numéro de série
    Any hand pieces repaired and returned from 9/18/08 to 10/10/08 may have the recalled bur guards.  Serial Numbers: 0414100533, 0414100563, 0509100113, 0509100153, 0723404443, 0719104803, 98030843, 0318200043, 0727604043, 0729800243, 98061133, 0329401103, 97060133,  0424700493, 95022553,  0225501513, 0326900083, 99020483,  0330800593, 96010273,  0318200013, 97010813,  0324102133, 96050103,  0225501563, 99050023,  94091003,  97060223,  97060243,  97060613,  97080253,  98080163,  98050533,  98020403,  0533401073, 97050523,  0428800503, 0713801143, 0633303273, 96070353,  0311401713, 00120423,  99050053,  01020103,  02010803,  96120423,  99090353,  0233004783, 98061203,  99090293,  99110863,  0428202963, 0624803663, 0719000333, 94121523,  99100013,  94080453,  97050833,  96090533,  97120983,  97120993,  99111173,  0726300403, 0726300413, 01070163,  01070173,  0409604363, 0418005013, 0528001463, 99010543,  0511800053, 0511800083, 0709208133, 98050813,  00020373,  97020173,  99100123,  97050823,  01040533,  0228902373, 0231700673, 99070473,  0313302433, 99010903,  0819605873, 95040843,  94120653,  0715001683, 95021513,  95021523,  98010663,  0230100243, 98100133,  99100073,  0713123243, 0415500963, 95011113,  0726708833, 95030323,  0230100233, 99090493,  00080073,  95100103,  95100113,  0230200313, 97040563,  99070123,  0316200853, 94090983,  00110113,  94111083,  99010683,  97110023,  98120993,  00030153,  0512301433, 94100163,  94121103,  94121113,  98010673,  96110383,  97110453,  0330700333, 97121623,  98100863,  0414900263, 0232500443, 95022133,  0414100543, 0414100553, 0414100613, 0509100133, 0723404483, 98111233,  95100203,  0734700603, 00080083,  98050053,  00120433,  99040403,  99100113,  0309902613, 0808801833, 0233801463, 0721406933, 94121903,  99080283,  0731614433, 0608304673, 0609004613, 0611506303, 0611506313, 0613003513, 0613003533, 0525500823, 96120233,  95110333,  0417601883, 0618101713, 0624205473, 94090153,  98120473,  97100113,  0233900963, 00100793,  00030163,  0225600983, 0231000193, 96020173,  95030143,  01090313,  0606604453, 0334600733, 98050113,  0231800503, 94120733,  94050013,  0715001663, 94122153,  95030993,  95120103,  94110683,  0635406433, 98081583,  99020373,  94070313,  99111033,  0315500203, 96070313,  0535500863, 0632200223, 0417601873, 0400500163, 0631003513, 97080383,  0621206363, 02010793,  0401402363, 0336400963, 0330901153, 0229100103, 0508201013, 0634605013, 0635406413, 95100603,  00060133,  0530602873, 98011083,  98021223,  97111273,  98120113,  97030263,  97050393,  97020163,  99100253,  97090053,  00040293,  0703902843, 0707903723, 97050563,  and 97090943.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Stryker Instruments, Kalamazoo, MI. || Intended to be used with impaction Drill. Drill is used for surgical procedures involving precision drilling and cutting of bone and hard tissue. The bur guard covers the nose of the handpiece and the shaft of the cutting accessory to prevent exposure to heat and moving parts, as well as minimize bur whip and handpiece vibration.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Portage MI 49002-9704
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA