Recall Z-1868-2017 ยท OLO Orthopedic Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
SmartTools Knee System Orthopedic Stereotaxic Instrument
| Date | Feb 20, 2017 |
| Status | Terminated |
| Reason | There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P |
| Root cause | Other |
| Action | Zimmer Biomet sent an Urgent Medical Device Recall - Lot Removal letter dated February 20, 2017, sent to the affected distributors and hospital Risk Managers and Surgeons via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Distributor responsibilities include: This letter is initiating Phase I of the lot specific field removal of the iASSIST Validation Tool field removal. You are receiving this letter because our records indicate that you |
| Quantity | 84 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122326 | SMARTTOOLS KNEE SYSTEM Zimmer, Nov 30, 2012 |