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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Impaction Bur Guard

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  Class 2 Device Recall Stryker Impaction Bur Guard see related information
Date Initiated by Firm January 27, 2009
Date Posted March 30, 2009
Recall Status1 Terminated 3 on December 17, 2009
Recall Number Z-1052-2009
Recall Event ID 50896
510(K)Number K961970  
Product Classification Surgical Instrument Ac-Powered Motor and Accessory - Product Code HWE
Product 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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Portage MI 49002-9704
For Additional Information Contact
800-800-4236 Ext. 4102
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 70
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWE and Original Applicant = STRYKER CORP.
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