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Terminated

ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.

FDA Recall Z-0010-2020 · Posted None

Recalling FirmImplant Direct Sybron Manufacturing, LLC
Recall StatusTerminated
Product CodeDZE
Date Initiated2018-08-07
Product Quantity158 devices

Reason for Recall

The incorrect device was packaged in the vial.

Firm Action

The recalling firm issued letters dated 8/7/2018 via FedEx or email on 8/7/2018 informing the consignee of the issue and requesting they review their inventory for the affected product and quarantine it until it is returned.

Root Cause

Employee error

Distribution Pattern

Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061319SPECTRA SYSTEMImplant Direct, LLC · 2006-09-29

Official Source

View FDA Recall →

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

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