CLASS II Device recall · Reported 28 Feb 2018 · FDA Enforcement Report
Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing /75 recalled
Zimmer Biomet is recalling Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing /75, distributed nationwide in the US. The recall was initiated on 29 Sep 2017 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-0674-2018
- FDA event ID
- 79161
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Sep 2017
- FDA classified
- 21 Feb 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 29 Sep 2017 | Recall initiated by company | |
| 21 Feb 2018 | Classified by FDA | +145 days |
| 28 Feb 2018 | 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
Knee implant components (tibial bearings) are labeled with the incorrect size.
Product as listed by the FDA
Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
Where it was distributed
Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
Nationwide CaliforniaGeorgiaKansasLouisianaMassachusettsMichiganMinnesotaOhioTexasVirginiaWashingtonWisconsin
Questions about this recall
Is Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing /75 recalled?
Yes. Zimmer Biomet recalled Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing /75 on 29 Sep 2017. The recall is Class II and its status is Terminated. Recall number Z-0674-2018.
Why was it recalled?
Knee implant components (tibial bearings) are labeled with the incorrect size.
Which lots are affected?
Lot Number: 473290, Exp. Date 5/19/2022
Where was it sold?
Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
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 | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |