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

Recall Z-0775-2016 — IMPLANT,TM, MTX 3.7 mm x 10 mm diameter 3.5 mm Catalog #TMMB10 Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate lo

U.S. FDA — Device Enforcement · United States · 2016-01-06 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0775-2016
Date of alert
2016-01-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Dental Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
63193919
Reported risk: Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.