CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report
Wright Inbone Tibial Tray, Size: 2, Plasma Spray, Left recalled
Wright Medical Technology is recalling Wright Inbone Tibial Tray, Size: 2, Plasma Spray, Left, distributed nationwide in the US. The recall was initiated on 9 Apr 2020 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-1924-2020
- FDA event ID
- 85439
- Recalling firm
- Wright Medical Technology, Arlington, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Apr 2020
- FDA classified
- 7 May 2020
- Reported
- 13 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 9 Apr 2020 | Recall initiated by company | |
| 7 May 2020 | Classified by FDA | +28 days |
| 13 May 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
One lot of INBONE Tibial Trays is missing the plasma coating.
Product as listed by the FDA
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
One lot of INBONE Tibial Trays is missing the plasma coating.
Which lots are affected?
Lot code 1619947
Where was it sold?
US Nationwide distribution.
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 26 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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