Z-0012-2019Class II

Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00

Name: Z-0012-2019 Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00
Creator: Exactech, Inc.
Published: 2018-08-21
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2018-08-21 / Open, Classified

FDA source

Exactech, Inc. began a recall of Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery on 2018-08-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0012-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-08-21
Posted: 2018-10-03
Recalling firm: Exactech, Inc.
Product: Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Product code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 2 units
Distribution: In the countries of Australia and France
Product codes and lots: Serial Numbers: 5214432, 5214445

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0012-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0012-2019	Class II	Ongoing	Voluntary: Firm initiated	2018-10-10	2018-10-02

Product code KWT

K063569Class IIEquinoxe Reverse Shoulder SystemExactech, Inc. / cleared 2007-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)