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

Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures — recall Z-0143-2019

U.S. FDA — Device Enforcement · United States · 2018-08-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0143-2019
Date of alert
2018-08-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Biomet, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
814313400
Reported risk: There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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