TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion
FDA device recall Z-3163-2024 · posted 2024-09-17 · Open, Classified
Recall details
- Recalling firm
- Innovasis, Inc
- Reason for recall
- Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.
- Action taken
- 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 this may come from an e-signature application (e.g., Adobe Sign, RightSignature, etc.). For questions/assistance, contact DPS at 801-261-2242 or support@innovasis.com during business hours Monday thru Friday 8:00 a.m. - 5:00 p.m. MST.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- MAX
- Quantity affected
- 568 devices
- Distribution
- U.S. Nationwide distribution in the states of AL, CA, CO, FL, ID, MI, SD, TX and WI.
- Date initiated
- 2024-08-14
- Date posted
- 2024-09-17
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TxTiHA IBF System, AxTiHA Stand-Alone ALIF System (K201614) | Innovasis, Inc. | 2020-07-15 |
| TxTi IBF System (K183064) | Innovasis, Inc. | 2019-06-28 |
| Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System (K180078) | Innovasis, Inc. | 2018-04-17 |