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
  • 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
  • 1 Event

Fabricant

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