FDA Device Recall Z-0010-2020: Implant Direct Sybron Manufacturing, LLC

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0010-2020.

Recall Res Number

Z-0010-2020

Recalling Firm / Manufacturer

Implant Direct Sybron Manufacturing, LLC

FEI Number

3001617766

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2018-08-07

Date Posted

N/A

Date Terminated

N/A

Product Code

DZE

Event Number

83086

Product Quantity

158 devices

Product Description 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.

Reason for Recall The incorrect device was packaged in the vial.

Action Details 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.

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.

Code Information / Serial Numbers Lot 108191, UDI (01)10841307108313(17)230118(10)108191

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Medical Device Recall: Z-0010-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer