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Terminated

Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.

FDA Recall Z-0007-2018 · Posted None

Recalling FirmImplant Direct Sybron Manufacturing, LLC
Recall StatusTerminated
Product CodeNHA
Date Initiated2017-07-21
Date Terminated2021-04-01
Product Quantity50 units

Reason for Recall

The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.

Firm Action

Recall notification letters were sent to consignees, via mail on 07/21/2107. Instructions included to review current inventory and remove affected product, to complete and return the Acknowledgement and Recall Return form, and to notify customers who received product if it was further distributed.

Root Cause

Employee error

Distribution Pattern

Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.

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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