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Terminated

Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty

FDA Recall Z-0980-2019 · Posted None

Recalling FirmStryker GmbH
Recall StatusTerminated
Product CodeLRO
Date Initiated2019-01-21
Date Terminated2020-04-02
Product Quantity17 units

Reason for Recall

The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.

Firm 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.

Root Cause

Employee error

Distribution Pattern

In the countries of Canada and Korea

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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