Events

Recall of Device Recall Stryker Impaction Bur Guard

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50896
  • Event Risk Class
    Class 2
  • Event Number
    Z-1052-2009
  • Event Initiated Date
    2009-01-27
  • Event Date Posted
    2009-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77614
  • Notes / Alerts
    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.
  • Extra notes in the data
    Surgical Instrument Ac-Powered Motor and Accessory - Product Code HWE
  • Reason
    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
  • Model / 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.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA