Recall Z-2455-2015 ยท FZX Guide, Surgical, Instrument
Omnilife Science Inc.
Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
| Date | Aug 24, 2015 (initiated Jun 9, 2015) |
| Status | Terminated |
| Reason | The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur. |
| Root cause | Device Design |
| Action | Omni sent an Urgent Medical Device -Field Safety Notice letters to their customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to Return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390. |
| Quantity | 15 |
| Distribution | Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.