Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard E
FDA device recall Z-0535-2013 · posted 2012-12-17 · Terminated
Recall details
- Recalling firm
- TITAN SPINE, LLC
- Reason for recall
- Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.
- Action taken
- Titan sent an Urgent Medical Device Recall letter dated October 19, 2012, to all affected customers. The letter described the problem , the product affected and the corrective measures to be taken. Customers were instructed to review any surgeries that were performed at the L5-51 level with the affected device. Customers were asked to communicate any complications associated with those cases to Titan Spine. Customers with questions should call 1-262-242-7801. For questions regarding this recall call 262-242-7801.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- MQP
- Quantity affected
- 92 pcs.
- Distribution
- Nationwide Distribution including NV
- Date initiated
- 2012-10-19
- Date posted
- 2012-12-17
- Date terminated
- 2013-01-14
- Location
- Mequon, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT (K032812) | Orthovita, Inc. | 2003-12-08 |