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

Recall Z-1986-2019 — Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench

U.S. FDA — Device Enforcement · United States · 2019-07-01 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1986-2019
Date of alert
2019-07-01
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Clariance Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
18710024
Reported risk: Potential for the polyaxial screw to become disassembled during implant.
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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