Device 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
Z-0780-2020
Product summary
- Firm
- Stryker GmbH
- Event
- Event 84458
- Status
- Terminated
- Classification
- Class II
- Quantity
- 433 (289 units U.S. / 144 units OUS)
- Official record key
device-enforcement:Z-0780-2020
Official wording
Reason: 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.
Code information: All lots UDI: (01)07613327350210
Distribution pattern: Worldwide distribution - US Nationwide distribution and countries of Switzerland, France, Spain, United Kingdom, Italy, Sweden, Netherlands, Australia.
Derived failure modes
-
Unknown
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.