Stryker MIS Bur, 2.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-125.
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-0596-2010
- 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, 06032017, 06065017, 06103017, 06179017, 07113017, 07143017, 07233017, 07291017, 07337017, 08007017, 08046017, 08107017, 08254017 and 09029017.
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.