Exactech, Inc.: Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

Is my product affected?

Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

• UPC 10885862086518

Check against the official notice below — it lists the full affected range.

What happened

Exactech, Inc. is recalling 2,278 units of its Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit due to a hazard where the screw head could become disengaged and not be retained in the Torque Defining Screwdriver. The affected product has Catalog Number 320-20-00 and was distributed worldwide, including throughout the United States, Puerto Rico, and multiple countries such as Canada, the United Kingdom, Australia, Germany, France, Spain, and Brazil.

The recalled units are identified by specific serial number ranges, beginning with serial 4410696 through 4423591 and continuing through serial 4542092, with the unique device identifier 10885862086518. The recall record does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver. 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, So Quantity: 2,278 units Lot/code info: 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

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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