PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 15, 2020 Initiated: December 5, 2019 #Z-0780-2020

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.

Details

Recalling Firm
Stryker GmbH
Units Affected
433 (289 units U.S. / 144 units OUS)
Distribution
Worldwide distribution - US Nationwide distribution and countries of Switzerland, France, Spain, United Kingdom, Italy, Sweden, Netherlands, Australia.
Location
Selzach, N/A

Frequently Asked Questions

What product 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. Recalled by Stryker GmbH. Units affected: 433 (289 units U.S. / 144 units OUS).
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 15, 2020. Severity: Moderate. Recall number: Z-0780-2020.