Zimmer Biomet recalls Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment (Model 185224) due to one bolt missing from sterile package. This could cause improper implant fixation.
“Zimmer Biomet Vanguard 36:1 Knee Implant Recall: Missing Bolt Hazard.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70204-zimmer-biomet-vanguard-36-1-knee-implant-recall-missing-bolt. Based on FDA recall #Z-3250-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3250-2018%22&limit=1).
The FDA announced on 2018-08-02 that Zimmer Biomet, Inc. voluntarily recalled the Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment because sterile packages contained only one bolt instead of the required two.
The hazard is that the implant only has one bolt in the sterile package but it should have had two.
Context
GovInfoNow's records show Zimmer Biomet, Inc. has 94 other recalls on record since 2017-06-05. Other recent recalls of similar products include Zimmer Persona Revision Femoral Distal Augment Recall (2026-05-11), U2 Total Knee System Femoral Offset Bushing Recall (2026-03-19), and U2 Total Knee System PSA Box Trial: Incomplete Screw Assembly Risk (2026-05-20).
How to tell if you have this one
Check for the model number 185224 on the implant package. This product was sold for total knee arthroplasty procedures.
Brand
Zimmer Biomet
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.
Recall number
Product, codes & lots
Z-3249-2018
Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty; Lot 320390, UDI (01) 0088030448157 (17) 230129 (10) 320390
Z-3250-2018
Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty; Lot 585070, UDI (01) 0088030448157 (17) 230215 (10) 585070
Based on the official FDA remedy
What to do — step by step
Check Package Details
Verify the model number 185224 on the implant package to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Kansas, Nevada, New Mexico, Utah.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3250-2018 (August 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3250-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.