Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing Template and
FDA device recall Z-2734-2011 · posted 2011-07-05 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Strike plate may dislodge from the broach stem handle during impaction of the device.
- Action taken
- Encore Medical, Lp (d.b.a. DJO Global) sent out a "Urgent Field Safety Notice" dated April 20, 2011 to all affected customers. The firm also e-mailed the consignees as well. The letter described the product, affected lots, reason for recall and provided recommendations including; asking customers contact firm for a replacement, provided a "Field Safety Response Form" to fill out and return. The firm also e-mailed the consignees as well. For additional information please contact the Director of Commercial Logistics at (512) 834-6330 or the International Customer Service at 512 834-6275.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HTQ
- Quantity affected
- 15 units
- Distribution
- Louisiana and Arkansas and the countries of Germany, Italy, United Kingdom and Japan.
- Date initiated
- 2011-04-21
- Date posted
- 2011-07-05
- Date terminated
- 2012-04-06
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.