Exactech, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0900-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

Product Classification:

Class II

Date Initiated: October 25, 2016

Date Posted: December 28, 2016

Recall Number: Z-0900-2017

Event ID: 75740

Reason for Recall:

Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.

Status: Terminated

Product Quantity: 2,278 units

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated