Z-0780-2020Class II

Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to...

Name: Z-0780-2020 Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to...
Creator: Stryker GmbH
Published: 2019-12-05
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-12-05 / Terminated

FDA source

Stryker GmbH began a recall of 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... on 2019-12-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0780-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-05
Posted: 2020-01-07
Terminated: 2020-10-09
Recalling firm: Stryker Corp.
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
Product code: HRS Plate, Fixation, Bone
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.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 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.
Product codes and lots: All lots UDI: (01)07613327350210

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0780-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0780-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-07

Product code HRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)