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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on October 21, 2020. Severity: Moderate. Recall number: Z-0097-2021.

Q: 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..

Q: 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.

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…

Recall #: Z-0097-2021
Affected scope: 48 devices
Initiated: September 3, 2020

Compiled from official public sources by the publisher. · Updated September 2026

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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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

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

Structured summary of the FDA Devices recall record
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.

Scale of Impact

48 devices units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

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? ▼

Why was this product recalled? ▼

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..

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.

Nationwide recalls with similar severity or category timing

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Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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This recall: FDA Devices, reported October 21, 2020. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026