FDA recall Z-0780-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-12-05

Report date

2020-01-15

Termination date

2020-10-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Selzach, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0780-2020