Use cautionMedical device recall · FDA · Published May 11, 2020
Biomet Comprehensive VRS Inserter Recall: Risk of Extended Surgery
Biomet recalls shoulder prosthesis inserters with specific serial numbers due to potential screw drill seizure causing extended surgery. Affected units include items with UDI codes (01)00880304829503 and lots 814100, 570640, 728890, 977300.
The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.
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📍Recalling firmBiomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
✎ GovInfoNow plain-language explainer
Biomet is recalling certain shoulder prosthesis inserters that may cause the central screw drill to seize during surgery, potentially requiring extended procedures to find a replacement device. This risk affects patients undergoing shoulder replacements with the specific model and serial numbers listed in the recall. Read more at govinfonow.com/recall/65191-biomet-comprehensive-vrs-inserter-recall-risk-of-extended-surgery.
“Biomet Comprehensive VRS Inserter Recall: Risk of Extended Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65191-biomet-comprehensive-vrs-inserter-recall-risk-of-extended-surgery. Based on FDA recall #Z-2300-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2300-2020%22&limit=1).
The FDA announced on May 11, 2020, that Biomet, Inc. is recalling the Comprehensive VRS Inserter shoulder prosthesis due to a central screw drill seizure hazard. The agency classified this Class II recall as voluntary and terminated.
The product is being recalled because the central screw drill may seize inside the Comprehensive VRS Inserter. This malfunction could lead to an extension of surgery to find a replacement device.
Context
GovInfoNow's records show Biomet, Inc. has had 28 other recalls on record since February 28, 2018. Other recent recalls of similar products include the Biomet Intramedullary Bone Saw Blade Recall (July 1, 2026), the Biomet ZipT recall (September 23, 2025), and the Biomet Juggerknot Mini Soft Anchors Recall (September 9, 2025). Other recent recalls of similar products include the ConMed Suture Anchor Recall (July 14, 2026), the restor3d Veritas Standard Glenoid Baseplate Recall (June 30, 2026), and the Zimmer Off-Axis Shoulder System Recall (May 20, 2026).
How to tell if you have this one
Check for the product name 'Comprehensive VRS Inserter' and the specific UDI codes (01)00880304829503 with lots 814100, 570640, 728890, or 977300. The device is used in shoulder replacement surgeries.
Identify the UDI code and lot number on the device to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution in the states of CA, FL, IN, KS, KY, MI, OH, and TX. Foreign distribution to Netherlands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Indiana, Kansas, Kentucky, Michigan, Ohio, Texas.
Recall timeline
FDA terminated this recall 6 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-2300-2020 (May 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2300-2020 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.