Recall Z-1701-2015 ยท OLO Orthopedic Stereotaxic Instrument
Zimmer CAS
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
| Date | Jun 2, 2015 (initiated Apr 19, 2015) |
| Status | Terminated |
| Reason | Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use. |
| Root cause | Device Design |
| Action | Zimmer distributed notices via certified mail on May 14, 2015. Zimmer is removing affected Tibial Alignment Guide iAssist Knee System product from distribution in a two-phased process. Based upon complaint investigation, Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use. Customerswere asked to review the notifictaion, follow the iASSIST Surgical Knee Technique provided, further distribute the notice for any distributed product, inspect devices in use before and af |
| Quantity | 78 devices |
| Distribution | Nationwide Distribution including AL, AZ, CA, CA, CO, FL, IN, MI, NJ, NY, OH, OR, PA, TX, VA, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122326 | SMARTTOOLS KNEE SYSTEM Zimmer, Nov 30, 2012 |