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

Recall Z-1913-2017 — RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)

U.S. FDA — Device Enforcement · United States · 2017-03-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1913-2017
Date of alert: 2017-03-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smith & Nephew, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 4500030972

Reported risk: The stability data does not support the product labeled with a 10-year shelf life.

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

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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.

Recall Z-1913-2017 — RENOVATION, THIN OSTEOTOME BLADE, 8 MM X 3 INCH, REF 71369208, STERILE R, QTY: (1)

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