Medical Device Recall: Z-0007-2018

FDA Recalls dataset · Firm: Implant Direct Sybron Manufacturing, LLC · Status: Terminated

Recall Action Class: N/A Date Initiated: 2017-07-21 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0007-2018.

Recall Res Number
Z-0007-2018
Recalling Firm / Manufacturer
Implant Direct Sybron Manufacturing, LLC
FEI Number
3001617766
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2017-07-21
Date Posted
N/A
Date Terminated
2021-04-01
Product Code
NHA
Event Number
77788
Product Quantity
50 units
Product Description Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Reason for Recall The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
Action Details 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.
Distribution Pattern Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
Code Information / Serial Numbers Product Code 9048-13H, Lot No. 81080

Related Establishments / Registrations

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