Device Recall Stryker Impaction Bur Guard

  • Modelo / Serial
    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.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    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
  • 1 Event

Fabricante

  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA