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

Recall Z-0872-2017 — 8450-010-040 4.0MM Round, 13CM, single use, Sterile The Stryker MIS (Minimally Invasive Surgery) product offering, is used to remove osseous material during surgical cases. Each cutting accessory consists of: " A shank (B) with a notch (A), that fits in the attachment on one end and is connecte

U.S. FDA — Device Enforcement · United States · 2016-11-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0872-2017
Date of alert: 2016-11-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Instruments Div. of Stryker Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 16060017

Reported risk: Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.

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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