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

Recall Z-0705-2022 — Everest MI XT Inner Dilator, Catalog Number 5101-90167

U.S. FDA — Device Enforcement · United States · 2022-01-13 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0705-2022
Date of alert
2022-01-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
K2M, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10888857261204
Reported risk: Stryker received two (2) complaints for units from specific lots of Inner and Outer Dilators not fitting together properly during a surgical procedure. Some dilators from these lots and from other lots were subsequently determined to be affected by a manufacturing nonconformance.
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.

Related

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.