CLASS II Device recall · Reported 2 Nov 2022 · FDA Enforcement Report
Stryker Inbone Tibial Tray, Left Plasma Spray Ti6Al4V, CPti recalled
Wright Medical Technology is recalling Stryker Inbone Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ Stem Base, distributed nationwide in the US. The recall was initiated on 30 Sep 2022 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-0140-2023
- FDA event ID
- 90965
- Recalling firm
- Wright Medical Technology, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Sep 2022
- FDA classified
- 27 Oct 2022
- Reported
- 2 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 30 Sep 2022 | Recall initiated by company | |
| 27 Oct 2022 | Classified by FDA | +27 days |
| 2 Nov 2022 | 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
The tibial tray lock detail is oversized (larger than specification).
Product as listed by the FDA
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Where it was distributed
US Nationwide distribution in the state of New York.
Questions about this recall
Is Stryker Inbone Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ Stem Base recalled?
Yes. Wright Medical Technology recalled Stryker Inbone Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ Stem Base on 30 Sep 2022. The recall is Class II and its status is Terminated. Recall number Z-0140-2023.
Why was it recalled?
The tibial tray lock detail is oversized (larger than specification).
Which lots are affected?
GTIN 00840420124159, Lot Code: 1725563
Where was it sold?
US Nationwide distribution in the state of New York.
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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| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |