Recall Z-3163-2024 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Innovasis, Inc
TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to
| Date | Sep 17, 2024 (initiated Aug 14, 2024) |
| Status | Open, Classified |
| Reason | Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device. |
| Root cause | Device Design |
| Action | On 08/14/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via email to customers informing them of interfacing issues between the implant trial and inserter of the Tx Systems. Customers are instructed to: 1. Please return trial sets to Innovasis for proper disposition. 2. Innovasis Distributor & Product Support (DPS) personnel will coordinate product replenishment with customers as needed. 3. Once all affected parts have been removed from inventory, a Product Removal Form will be issued to customers. This form must be filled, signed and returned for regulatory purposes. Note that |
| Quantity | 568 devices |
| Distribution | U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI. |
| FDA record | Open on fda.gov |