Z-0900-2017Class II

Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

Name: Z-0900-2017 Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Creator: Exactech, Inc.
Published: 2016-10-25
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2016-10-25 / Terminated / root cause: design

FDA source

Exactech, Inc. began a recall of Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit on 2016-10-25. FDA classified it as Class II and gives the reason as "Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0900-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-25
Posted: 2016-12-22
Terminated: 2019-07-26
Recalling firm: Exactech, Inc.
Product: Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Product code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Reason for recall: Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
Root cause tag: design
FDA root cause: Component design/selection
Action: Exactech sent an Advisory Notice on October 25, 2016, to Exactech field agents in the U.S. Agents outside of the U.S. were notified on November 2, 2016. Field agents were notified of the recall in the Advisory Notice and asked to notify their accounts that may have the recalled product in stock. Agents were required to complete and return the Field Advisory Notice Response Form within 5 working days. For further questions, please call (352) 377-1140.
Quantity in commerce: 2,278 units
Distribution: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MD, ME, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TN, VA, WA and WI., and to the countries of : Austria, Australia, Canada, Germany, France, Spain, India, Switzerland, Italy, South Korea, United Kingdom, Brazil, Luxembourg, Greece, Guatemala, Netherlands, South Africa, and Sweden
Product codes and lots: Catalog No. 320-20-00; Unique Device Identifier 10885862086518; Serial Range 4410696-4410819, 4415393-4415492, 4418789-4418888, 4422658-4423007, 4423542-4423591, 4424509-4424558, 4458153-4458252, 4458303-4458352, 4461732-4461806, 4464592-4464691, 4467733-4467824, 4471099-4471298, 4485494-4485543, 4488224-4488260, 4504738-4504987, 4513150-4513199, 4513250-4513299, 4517116-4517215, 4519806-4520005, 4533291-4533390, 4542043-4542092.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0900-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0900-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

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)