Stryker Instruments Div. of Stryker Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Stryker Instruments Div. of Stryker Corporation
Lot Codes / Batch Numbers
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.
Products Sold
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.
Stryker Instruments Div. of Stryker Corporation is recalling Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Stryker Instruments, K due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026