Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135.
This recall has been terminated (originally issued January 11, 2010).
- Recall Initiated
- July 6, 2009
- Posted
- January 11, 2010
- Terminated
- October 25, 2010
- Recall Number
- Z-0598-2010
- Quantity
- 5438 of all products
- Firm Location
- Kalamazoo, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.
Distribution
Nationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan.
Lot / Code Info
All lots distributed 1/30/06 through 3/4/09. Lots 05363017, 06037017, 06069027, 06094017, 06165017, 06240017, 06275017, 06305017, 06354017, 07029017, 07079017, 07080017, 07108017, 07143017, 07219017, 07233017, 07290017, 07333017, 08021017, 08038017, 08049017, 08098017, 08155017, 08156017, 08253017, 08337017 and 09054017.
Root Cause
Device Design
Action Taken
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.