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

Recall Z-1245-2018 — 1. Femoral Canal Pressurizer without Hub, Medium, Blue, Product Number: 0206-546-000, UDI: (01)4546540039552; 2. Femoral Canal Pressurizer without Hub, Large, Red, Product Number: 0206-547-000, UDI: (01)4546540039569 for orthopedic use.

U.S. FDA — Device Enforcement · United States · 2017-11-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1245-2018
Date of alert
2017-11-09
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)
17276012
Reported risk: Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
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.

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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.