Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 21, 2020
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750 (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID: It
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 dat…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Biomet, Inc. recalled (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antio… - a moderate-severity action.
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antio… was recalled by Biomet, Inc. in October 21, 2020. Reason: Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabu…. Check the official notice for the remedy. Verify recall #Z-0097-2021 with the FDA Devices before acting.
The recall
Biomet, Inc. issued this moderate-severity FDA Devices recall-Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip system Acetabu….
- Moderate
- severity level
- 48 units
- affected scope
- Class II
- classification
- October 21, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0097-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0097-2021) was formally reported on October 21, 2020, with the manufacturer initiating the action on September 3, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomet, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 48 devices.
The documented reason for this recall is: 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 function… Distribution data in the federal record shows the product reached: 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 unit…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
48 devices
Related Recalls
6
3 from same agency
Product description
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750 (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID: Item No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0097-2021 |
| Date reported | October 21, 2020 |
| Date initiated | September 3, 2020 |
| Recalling firm | Biomet, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 48 devices |
| 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 subje… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0097-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup, ArCom, 41 MM OD, 28 MM ID: Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750 (3) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Cup, ArCom, 52 MM OD, 28 MM ID: Item No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290. Recalled by Biomet, Inc.. Units affected: 48 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 21, 2020. Severity: Moderate. Recall number: Z-0097-2021.
Where was the recalled product distributed? ▼
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 subject to removal..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0097-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 21, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.