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

Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512 — recall Z-2535-2016

U.S. FDA — Device Enforcement · United States · 2016-07-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2535-2016
Date of alert
2016-07-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Straumann Manufacturing, Inc.
Product category
device
Product type
Devices
Reported risk: Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration
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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