Use cautionMedical device recall · FDA · Published December 1, 2020
Biomet Vanguard 36: Incorrect Tibial Bolts May Delay Knee Surgery
Biomet recalls Vanguard 360 Revision System Posterior Augment With Bolt due to incorrect tibial bolts in package that may delay knee surgery procedures.
“Biomet Vanguard 36: Incorrect Tibial Bolts May Delay Knee Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63755-biomet-vanguard-36-incorrect-tibial-bolts-may-delay-knee-surgery. Based on FDA recall #Z-0723-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0723-2021%22&limit=1).
The FDA announced on Dec. 1, 2020, that Biomet, Inc. is recalling the Vanguard 360 Revision System Posterior Augment With Bolt due to a hazard involving incorrect bolts in the package. This voluntary Class II recall affects 21 units distributed worldwide, including in Florida, Korea, Japan, and the Netherlands.
How to tell if you have it
Brand: Biomet
Product: Vanguard 360 Revision System Posterior Augment With Bolt
According to the FDA, tibial bolts may be included in the package instead of the required femoral bolts. This error could delay the surgical procedure for users of this knee arthroplasty device.
Context
GovInfoNow's records show Biomet, Inc. has had 28 other recalls on record since Feb. 28, 2018. Recent brand recalls include a July 1, 2026 recall for Intramedullary Bone Saw Blades due to sterile packaging risk and a Sept. 23, 2025 recall for ZipT implants involving missing buttons. Other recent recalls of similar products include the March 19, 2026 U2 Total Knee System Femoral Offset Bushing Recall and the Jan. 5, 2026 Encore Medical EMPOWR 3D Knee Tibial Insert 5R 14MM Recall.
How to tell if you have this one
Check for the item number 185422 and lot number 098780 on the packaging. The UDI number is (01) 00880304482739 (17) 290501 (10) 098780.
Brand
Biomet
Product
Vanguard 360 Revision System Posterior Augment With Bolt
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Packaging
Look for item number 185422 and lot number 098780 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the state of FL and the countries of Korea, Japan, Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 19 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-0723-2021 (December 1, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0723-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.