Z-0980-2019Class II

Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900

Name: Z-0980-2019 Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900
Creator: Stryker GmbH
Published: 2019-01-21
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-01-21 / Terminated / root cause: manufacturing process

FDA source

Stryker GmbH began a recall of Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty on 2019-01-21. FDA classified it as Class II and gives the reason as "The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0980-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-21
Posted: 2019-03-06
Terminated: 2020-04-02
Recalling firm: Stryker Corp.
Product: Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Product code: LRO General Surgery Tray
Reason for recall: The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Zimmer Biomet issued Urgent Field Safety Notice PFA 1982723 customer letter dated: January 21, 2019. Letter identifies affected product, problem and action to be taken: Inform individuals within your organization who need to be aware of this action. 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. Response is required, even you may not have any physical inventory on site anymore. 3. Quarantine and discontinue use of the devices.
Quantity in commerce: 17 units
Distribution: In the countries of Canada and Korea
Product codes and lots: Lot Number(s): K026ACE (lot# packaging) KU97181 (Vendor code engraved on device)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0980-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0980-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-06

Product code LRO

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

MDM coverage of this record lists here, newest first.

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)