Z-0900-2017 Class II Terminated
FDA device recall Z-0900-2017 was initiated by Exactech, Inc. on Oct 25, 2016 and is designated Class II. Reason for recall: Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver. The recall status is terminated (terminated Jul 26, 2019). Affected quantity: 2,278 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 28, 2016
- Initiation Date
- Oct 25, 2016
- Termination Date
- Jul 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,278 units
Product Description
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Reason for Recall
Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
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
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0900-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026