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

Recall Z-0592-2017 — Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System cons

U.S. FDA — Device Enforcement · United States · 2016-10-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0592-2017
Date of alert: 2016-10-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Alphatec Spine, Inc.
Product category: device
Product type: Devices

Reported risk: Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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