Medical Device Recall: Z-0012-2019

FDA Recalls dataset · Firm: Exactech, Inc. · Status: Open, Classified

Recall Action Class: N/A Date Initiated: 2018-08-21 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0012-2019.

Recall Res Number
Z-0012-2019
Recalling Firm / Manufacturer
Exactech, Inc.
FEI Number
1038671
Recall Status
Open, Classified
Recall Classification
N/A
Date Initiated
2018-08-21
Date Posted
N/A
Date Terminated
N/A
Product Code
KWT
Event Number
80996
Product Quantity
2 units
Product Description Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Reason for Recall The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.
Action Details The firm disseminated the field safety notice by email on 08/21/2018. The notice requested the following actions: " Immediately cease distribution or use of this product. " Extend the information to their accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in their inventory " Complete and return the attached Recall Acknowledgment Form and Recall Inventory Response Form to Exactech.
Distribution Pattern In the countries of Australia and France
Code Information / Serial Numbers Serial Numbers: 5214432, 5214445

Related Establishments / Registrations

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