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

Recall Z-3204-2017 — Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223

U.S. FDA — Device Enforcement · United States · 2017-07-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3204-2017
Date of alert
2017-07-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Dental Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
63062148
Reported risk: Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.
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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