Agency classClass IIOur severity:High FDA (Devices)·Z-0097-2021·Announced 2020-10-21

Biomet Recalls RingLoc Hip Cups Due to Double Sterilization

Biomet is recalling 48 RingLoc Bi-Polar Hip System Acetabular Cups because they were gamma sterilized twice, which may compromise functionality and shelf life.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device where the hazard is theoretical (lack of data on functionality/shelf life) and no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Biomet, Inc. is conducting a recall for three lots of the RingLoc Bi-Polar Hip System Acetabular Cup. The affected devices were gamma sterilized twice. The company states that sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.

A total of 48 devices were distributed nationwide and to locations outside the United States. Approximately 14 units have been previously implanted, one unit was returned prior to the recall, and 33 units remain in the field subject to removal.

Healthcare providers should identify any patients who have received these specific implants and contact Biomet for instructions on removal. Patients who have had these devices implanted should contact their healthcare provider to discuss the recall and potential next steps.

The recalled product

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…
Manufacturer: Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: sterilization-defect
device-failure
Affected units: 48

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

(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
ArCom
41 MM OD
28 MM ID: Item No. 11-165206
Lot No. 649750
UDI No. (01) 00880304001923 (17) 230614 (10) 649750
52 MM OD
28 MM ID: Item No. 11-165228
Lot No. 433290
UDI No. (01) 00880304001930 (17) 230612 (10) 433290
EXP Date June 12th 2023

Distribution

Distributed nationwide across the United States.

Same manufacturer · Biomet, Inc.

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Same hazard · sterilization defect