Z-0780-2020 Class II Terminated

Recalled by Stryker GmbH — Selzach, N/A

Recall Details

Product Type
Devices
Report Date
January 15, 2020
Initiation Date
December 5, 2019
Termination Date
October 9, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
433 (289 units U.S. / 144 units OUS)

Product Description

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

Reason for Recall

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.

Distribution Pattern

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

Code Information

All lots UDI: (01)07613327350210