Recall Z-2966-2018 ยท LXH Orthopedic Manual Surgical Instrument
Exactech, Inc.
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
| Date | Jul 13, 2018 |
| Status | Terminated |
| Reason | Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads 10885862525629, when it should read 10885862525628. |
| Root cause | Employee error |
| Action | The firm notified their direct consignees by email on 07/13/2018 and requested the return of the product. |
| Quantity | 7 units |
| Distribution | CA, OH, NY, OK, FL, TX, SC, Germany, Spain, Switzerland, and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152217 | Exactech Vantage Total Ankle System Exactech, Inc., Mar 10, 2016 |