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

SwishTapered Implant — recall Z-1112-2017

U.S. FDA — Device Enforcement · United States · 2016-12-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1112-2017
Date of alert
2016-12-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Implant Direct Sybron Manufacturing, LLC
Product category
device
Product type
Devices
Reported risk: The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
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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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.