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

Recall Z-1189-2018 — Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.

U.S. FDA — Device Enforcement · United States · 2017-11-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1189-2018
Date of alert
2017-11-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Dental Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
63621027
Reported risk: Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
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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