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

Recall Z-0629-2017 — DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm Item Code: 186862018 The SKYLINE¿ Anterior Cervical Plate System is indicated for stabilization from C2 to C7 for degenerative disc disease (DDD) (defined as back pain of discogenic origin with degenerat

U.S. FDA — Device Enforcement · United States · 2016-10-12 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0629-2017
Date of alert: 2016-10-12
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DePuy Spine, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 186862018

Reported risk: SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

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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