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

Recall Z-1920-2018 — ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.

U.S. FDA — Device Enforcement · United States · 2016-11-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1920-2018
Date of alert
2016-11-15
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 vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
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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