—#77614

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.

FDA product code: HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K961970
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Portage, Michigan 49002-9704

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2009-01-27
Posted by FDA: 2009-03-30
Terminated: 2009-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #77614. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.