Equinoxe recallZ-0900-2017 · Exactech, Inc. · initiated Oct 25, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
FDA root cause category: Component design/selection
What the company is doing
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.
Recall details
- Recall number
- Z-0900-2017
- Status
- Terminated
- Initiated by the company
- Oct 25, 2016
- Recalling firm
- Exactech, Inc.
- Quantity
- 2,278 units
- Product code
- KWT
- FDA submissions
- K063569
- 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 description
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Equinoxe 320-20-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall42 reports
Product lines
Other devices under the same FDA submission
44 devices cleared under K063569 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Equinoxe 320-38-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 recalls107 reports
- Equinoxe 320-42-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls87 reports
- Equinoxe 320-38-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls43 reports
- Equinoxe 320-42-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls41 reports
- Equinoxe 320-10-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented132 reports
- Equinoxe 320-42-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls14 reports
- Equinoxe 320-38-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls12 reports
- Equinoxe 320-46-13Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls5 reports
- Equinoxe 320-46-10Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 recalls3 reports
- Equinoxe 320-46-03Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall23 reports
- Equinoxe 320-46-00Exactech, Inc. · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 recall22 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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