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Terminated

Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135.

FDA Recall Z-0598-2010 · Posted 2010-01-11

Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product CodeHBE
Date Initiated2009-07-06
Date Terminated2010-10-25
Product Quantity5438 of all products

Reason for Recall

The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.

Firm Action

Consignees were sent a letter dated 7/10/09 instructing them to locate and return product on hand for replacement. Surgeons who use the product were notified via a separate, untitled letter, dated July 13, 2009. A speed warning will be added to the product labels. Questions are directed to the firm at: 1-800-800-4236 ext. 3808.

Root Cause

Device Design

Distribution Pattern

Nationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040300STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)Stryker Instruments · 2004-03-03K032303STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMStryker Instruments · 2004-01-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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