RecallRadar

FDA Device recall Z-0900-2017

Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

On 2016-12-28 the FDA classified a Class II recall of Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit by Exactech, citing disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0900-2017
ClassificationClass II
Statusterminated
Initiated2016-10-25
Published2016-12-28
Last updated2026-09-13 11:54 UTC
CompanyExactech
DistributionUS

Product

Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit

Reason

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

Identifiers

code_info
Catalog No. 320-20-00; Unique Device Identifier 10885862086518; Serial Range 4410696-4410819, 4415393-4415492, 4418789-…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.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0900-2017%22

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