Reported Dec 28, 2016 · Terminated

Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

Exactech, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Exactech, Inc. · 2320 NW 66th Ct · Gainesville, FL · 32653-1630

Is this the product you have?

  • Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Lot codes and dates

3 of 3 products

Products covered by this recall
Model / numberBarcodesProduct as published
320-20-00
10885862086518Unique 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.
Amount recalled
2,278 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 26, 2019 · Data as of Sep 19, 4:51 PM UTC

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