Recalls / —
—#81885
Product
Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. Vacuum mixing and vacuum collection system and application system for bone cement.
- FDA product code
- JDZ — Mixer, Cement, For Clinical Use
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Lot Number: 607452.
Why it was recalled
The package may contain two short mixing rods instead of one long and one short rod.
Root cause (FDA determination)
Packaging process control
Action the firm took
Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated April 9, 2009 instructing distributors to visit each hospital consignee, deliver a copy of the recall notification and replacement product and to pick up, and return the affected product. Further questions may be addressed to the Biomet Orthopedics at 1-800-348-9500.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582
Distribution
- Distribution pattern
- Nationwide Distribution - Including AL, AR, FL, IL, LA, MN, NE, NC, NV, OH, OK, SC, SD, WA and WI.
Timeline
- Recall initiated
- 2009-04-09
- Posted by FDA
- 2009-06-30
- Terminated
- 2010-10-06
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #81885. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.