Z-0780-2020 Class II Terminated
FDA device recall Z-0780-2020 was initiated by Stryker GmbH on December 5, 2019 and is designated Class II. 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. The recall status is terminated (terminated October 9, 2020). Affected quantity: 433 (289 units U.S. / 144 units OUS).
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