Product Wiki · Recalls · U.S. FDA — Device Enforcement

Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended for use in the thora — recall Z-0535-2013

U.S. FDA — Device Enforcement · United States · 2012-10-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0535-2013
Date of alert: 2012-10-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: TITAN SPINE, LLC
Product category: device
Product type: Devices

Reported risk: Titan Spine LLC, is conducting a recall on the Endoskeleton TA VBR products. The labeling accompanying this device contains incorrect indications for use.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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