FDA Medical Device Recalls (openFDA)
Stryker GmbH: Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
- Recall number
- Z-0980-2019
- Recalling firm
- Stryker GmbH
- Product
- Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
- Status
- Terminated
- Initiated
- 2019-01-21
- Posted
- not on file
- Terminated
- 2020-04-02
- Reason
- The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
- 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
- 17 units
- Distribution
- In the countries of Canada and Korea
- Lot, serial or model codes
- Lot Number(s): K026ACE (lot# packaging) KU97181 (Vendor code engraved on device)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 3002807830
- Firm city
- Selzach
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28