# FDA recall Z-0097-2021

> **Biomet, Inc.** · Class II · device recall initiated 2020-09-03.

## Product

(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.

## 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.

## Key facts

- **Recall number:** Z-0097-2021
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-03
- **Report date:** 2020-10-21
- **Termination date:** 2022-12-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0097-2021

## Citation

> AI Analytics. FDA recall Z-0097-2021. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0097-2021. Source: US FDA. Licensed CC0.

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