Stryker T2 Alpha Delta Strike Plate IMN Instruments - part… recallZ-0780-2020 · Stryker GmbH · initiated Dec 5, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Stryker issued Urgent Medical Device Recall Letter (PFA# 2219868) to US consignees on 5-Dec-2019 , letter states reason for recall, health risk and action to take: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2.Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3.Quarantine and discontinue use of the recalled devices. 4. Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply. An OUS customer letter was also issued at the country level.
Recall details
- Recall number
- Z-0780-2020
- Status
- Terminated
- Initiated by the company
- Dec 5, 2019
- Recalling firm
- Stryker GmbH
- Quantity
- 433 (289 units U.S. / 144 units OUS)
- Product code
- HRS
- Distribution
- Worldwide distribution - US Nationwide distribution and countries of Switzerland, France, Spain, United Kingdom, Italy, Sweden, Netherlands, Australia.
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
Code information (models, lots, serial numbers)
All lots UDI: (01)07613327350210
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA 2351-0050Stryker GmbH · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 recall33 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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