Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw,
FDA device recall Z-1480-2009 · posted 2009-06-30 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The package may contain two short mixing rods instead of one long and one short rod.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JDZ
- Quantity affected
- 250
- Distribution
- Nationwide Distribution - Including AL, AR, FL, IL, LA, MN, NE, NC, NV, OH, OK, SC, SD, WA and WI.
- Date initiated
- 2009-04-09
- Date posted
- 2009-06-30
- Date terminated
- 2010-10-06
- Location
- Warsaw, IN
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