Recall Z-2734-2011 ยท HTQ Broach
Encore Medical, Lp
Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial baseplate stem.
| Date | Jul 5, 2011 (initiated Apr 21, 2011) |
| Status | Terminated |
| Reason | Strike plate may dislodge from the broach stem handle during impaction of the device. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 15 units |
| Distribution | Louisiana and Arkansas and the countries of Germany, Italy, United Kingdom and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.