Recall Z-2127-2016 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Exactech, Inc.
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for an
| Date | May 26, 2016 |
| Status | Terminated |
| Reason | Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another. |
| Root cause | Under Investigation by firm |
| Action | Exatech sent an Important Notification letter dated May 16, 2016, to all affected customers. The letter notified customers of the product's incorrect Global Trade Item Number. Customers were instructed to cease distribution/use of the product, extend the information to accounts possessing the recalled product, identify and quarantine any devices in inventory, and to complete and return the Recall Inventory Response Form acknowledging that they received the recall notification. Customers were instructed to call 800-392-2832 with any questions. For questions regarding this recall call 352-377- |
| Quantity | 8 units |
| Distribution | Nationwide Distribuiton to OK, ME, NY, & Hawaii. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063279 | NOVATION SPLINED RDD FEMORAL STEMS Exactech, Inc., Nov 29, 2006 |