Recalls / —

—#151122

Product

Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

FDA product code

KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K063569

Affected 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.

Why it was recalled

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

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

Firm

Exactech, Inc.

Address

2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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

Timeline

Recall initiated

2016-10-25

Terminated

2019-07-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #151122. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.