CLASS II Device recall · Reported 28 Nov 2018 · FDA Enforcement Report
Vanguard Knee System -PS Open Box Femoral Left recalled by Zimmer Biomet
Zimmer Biomet is recalling Vanguard Knee System -PS Open Box Femoral Left, distributed in 7 states. The recall was initiated on 22 Oct 2018 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-0495-2019
- FDA event ID
- 81472
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Oct 2018
- FDA classified
- 21 Nov 2018
- Reported
- 28 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 22 Oct 2018 | Recall initiated by company | |
| 21 Nov 2018 | Classified by FDA | +30 days |
| 28 Nov 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
Label on the outer carton or the patient labels does not match label on the inner sterile packaging
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
Where it was distributed
AR, MO, MN, NJ, NY, OH, MN , NJ, VA
Questions about this recall
Is Vanguard Knee System -PS Open Box Femoral Left recalled?
Yes. Zimmer Biomet recalled Vanguard Knee System -PS Open Box Femoral Left on 22 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0495-2019.
Why was it recalled?
Label on the outer carton or the patient labels does not match label on the inner sterile packaging
Which lots are affected?
Lot Number: J6255863 UDI: (01)00880304270794(17)280411(10)J6265594
Where was it sold?
AR, MO, MN, NJ, NY, OH, MN , NJ, VA
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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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| 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 |