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

Recall Z-1412-2013 — 40 mm Rod, Item #BG1640 Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intend

U.S. FDA — Device Enforcement · United States · 2013-02-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1412-2013
Date of alert: 2013-02-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Spinal Solutions, LLC
Product category: device
Product type: Devices

Reported risk: The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

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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