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

Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined — recall Z-1350-2018

U.S. FDA — Device Enforcement · United States · 2018-01-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1350-2018
Date of alert: 2018-01-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Neuropro Spinal Jaxx
Product category: device
Product type: Devices

Reported risk: The implant size is incorrectly etched on the implant. The size listed on the box is correct.

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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