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

Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-steril — recall Z-1146-2015

U.S. FDA — Device Enforcement · United States · 2012-11-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1146-2015
Date of alert: 2012-11-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet Spine, LLC
Product category: device
Product type: Devices

Reported risk: Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification

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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