CLASS II Device recall · Reported 13 Mar 2019 · FDA Enforcement Report
Instrument Tray, Basic T2 Femur Long recalled by Stryker
Stryker is recalling Instrument Tray, Basic T2 Femur Long. The recall was initiated on 21 Jan 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0980-2019
- FDA event ID
- 82140
- Recalling firm
- Stryker, Selzach, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jan 2019
- FDA classified
- 6 Mar 2019
- Reported
- 13 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 21 Jan 2019 | Recall initiated by company | |
| 6 Mar 2019 | Classified by FDA | +44 days |
| 13 Mar 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
Product as listed by the FDA
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Where it was distributed
In the countries of Canada and Korea
Questions about this recall
Is Instrument Tray, Basic T2 Femur Long recalled?
Yes. Stryker recalled Instrument Tray, Basic T2 Femur Long on 21 Jan 2019. The recall is Class II and its status is Terminated. Recall number Z-0980-2019.
Why was it recalled?
The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
Which lots are affected?
Lot Number(s): K026ACE (lot# packaging) KU97181 (Vendor code engraved on device)
Where was it sold?
In the countries of Canada and Korea
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |