Stryker MIS Bur, 3.0mm Neuro Diamond Course, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-230.
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-0599-2010
- 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 07352017, 08043017 and 08350027.
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.