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Terminated

GoDirect Screw-Retaining Top Part Numbers: 4500-61

FDA Recall Z-0961-2017 · Posted 2017-01-09

Recalling FirmImplant Direct Sybron Manufacturing, LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2016-11-28
Date Terminated2017-02-16
Product Quantity14

Reason for Recall

Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

Firm Action

On 11/28/16 customers were called and instructed to return the product.

Root Cause

Labeling mix-ups

Distribution Pattern

U.S. distribution to the following; WA. Foreign distribution to the following; Netherlands.

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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