Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet Orthopedics, I
FDA device recall Z-0367-2010 · posted 2009-11-19 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a diameter of .062 inches.
- Action taken
- An "Urgent Medical Device Recall Notice" dated August 6, 2009 was issued to consignees. The letter described the affected product, issue and actions for consignees. Customers were instructed to complete and return the "FAX back Response Form" (fax number 1-574-372-1683) and all affected product in inventory to Biomet Orthopedics. Direct questions related to the recall notification by calling at 1-800-348- 9500 or 1-574-372-3983, Monday through Friday, 8AM to 5PM.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FZX
- Quantity affected
- 19
- Distribution
- United States (Florida and Pennsylvania).
- Date initiated
- 2009-08-06
- Date posted
- 2009-11-19
- Date terminated
- 2010-10-06
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.