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Terminated

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.

FDA Recall Z-1920-2018 · Posted None

Recalling FirmImplant Direct Sybron Manufacturing, LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2016-11-15
Date Terminated2018-06-04
Product Quantity18 units

Reason for Recall

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.

Firm Action

Letters dated 11/14/2016 were issued via FedEx overnight on 11/15/2016.

Root Cause

Labeling mix-ups

Distribution Pattern

Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090234SPECTRA SYSTEM DENTAL IMPLANTS 2008Implant Direct, LLC · 2009-05-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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