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

Recall Z-0154-2015 — Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a c

U.S. FDA — Device Enforcement · United States · 2014-10-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0154-2015
Date of alert: 2014-10-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Zimmer Dental Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 62659204

Reported risk: Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.

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.

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.

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