Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Stryker Instruments, Kalamazoo, MI. Intend

FDA device recall Z-1052-2009 · posted 2009-03-30 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

HWE

Quantity affected

70

Distribution

Nationwide Distribution

Date initiated

2009-01-27

Date posted

2009-03-30

Date terminated

2009-12-17

Location

Portage, MI

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