Stryker GmbH recalls Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support inserti…

Recall date

December 5, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0780-2020

FDA classification

Class II

Brand / firm

Stryker GmbH

Sold / distributed

Worldwide distribution - US Nationwide distribution and countries of Switzerland, France, Spain, United Kingdom, Italy, Sweden, Netherlands, Australia.

Why it was recalled

Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications during nail insertion and removal.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support insertion and withdrawal of nails through the Targeting Device Catalog Number: 2351-0050