Lower riskMedical device recall · FDA · Published September 3, 2020
Biomet Hip Cup Recall: Double Sterilization May Cause Failure
Biomet recalls three lots of acetabular hip cups due to insufficient data after double gamma sterilization. These hip implants may fail prematurely, risking complications. Affected units have specific lot numbers and expiration dates.
Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabular Cup. The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.
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Contact the company
📍Recalling firmBiomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
✎ GovInfoNow plain-language explainer
Biomet is recalling three specific lots of hip replacement cups because they were sterilized twice, which the company says doesn't support their safety or shelf life. This could lead to the implants failing earlier than expected, causing health issues for users. Read more at govinfonow.com/recall/64381-biomet-hip-cup-recall-double-sterilization-may-cause-failure.
“Biomet Hip Cup Recall: Double Sterilization May Cause Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64381-biomet-hip-cup-recall-double-sterilization-may-cause-failure. Based on FDA recall #Z-0097-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0097-2021%22&limit=1).
The FDA announced on Sept. 3, 2020, that Biomet, Inc. is recalling three lots of the RingLoc Bi-Polar Hip System Acetabular Cup because double gamma sterilization compromises functionality and shelf life. The agency classified the recall as Class II.
How to tell if you have it
RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM
RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID
RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID
Item No. 110010458; Lot No. 710930
Item No. 11-165206; Lot No. 649750
Item No. 11-165228; Lot No. 433290
The hazard
The affected lots were gamma sterilized twice, and sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.
Context
GovInfoNow's records show Biomet, Inc. has 28 other recalls on record since Feb. 28, 2018. Other recent recalls of similar products include Biomet Intramedullary Bone Saw Blade Recall (July 1, 2026), Biomet ZipT (Sept. 23, 2025), and Biomet Juggerknot Mini Soft Anchors Recall (Sept. 9, 2025). Other recent recalls of similar products include Medline Recalls Knee Surgery Kits Due to Sterility Risk (June 10, 2026), Argon Medical Devices General Biospy Tray Recall (June 1, 2026), and Medline Convenience Kits Recall (Jan. 7, 2026).
How to tell if you have this one
Check for the lot number (e.g., 710930, 649750, 433290) or expiration date (June 14, 2023, or June 12, 2023) on the product packaging. The product names include 'RingLoc Bi-Polar Hip System Acetabular Cup ArCom' with specific sizes.
Brand
Biomet
Product
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number or expiration date on the packaging to confirm if your hip cup is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Devices were distributed nationwide throughout the United States and to locations OUS. There has been one unit returned prior to the recall and approximately 14 units that have been previously implanted, leaving 33 units in the field…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years 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-0097-2021 (September 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0097-2021 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.