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

Recall Z-0127-2014 — Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material.

U.S. FDA — Device Enforcement · United States · 2013-11-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0127-2014
Date of alert
2013-11-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Instruments Div. of Stryker Corporation
Product category
device
Product type
Devices
Reported risk: Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of m
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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