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U.S. Department of Health and Human Services

Class 2 Device Recall RingLoc BiPolar Hip System Acetabular Cup

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  Class 2 Device Recall RingLoc BiPolar Hip System Acetabular Cup see related information
Date Initiated by Firm September 03, 2020
Date Posted October 09, 2020
Recall Status1 Open3, Classified
Recall Number Z-0097-2021
Recall Event ID 86382
510(K)Number K051569  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
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
Code Information (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; EXP Date June 14th 2023  (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; EXP Date June 14th 2023  (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; EXP Date June 12th 2023
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Kevin W. Escapule
574-372-4487
Manufacturer 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.
FDA Determined
Cause 2
Process control
Action All affected customers were sent a letter on 09/03/2020 stating the following : 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. Zimmer Biomet will follow up w/ consignees that have not responded after the initial notification. Additional notifications via telephone, fax, email, or traceable carrier will be sent to those who have not completed the required certification form or provided surgeon and hospital information/confirmation. 100% of the delivery notifications will be accounted for. An inventory return certification form will be returned from each distributor that certifies that all available products from their territory have been returned or accounted for. Affected products that are not returned or accounted for will be considered as "not in inventory and unavailable for return." Zimmer Biomet will deem accounts unresponsive after 3 effectiveness checks if there continues to be no response are making reasonable efforts. Product that has not been recovered rom unresponsive consignees will be reported as unaccounted for. Product returned from the field will be scrapped.
Quantity in Commerce 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 subject to removal.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JDI and Original Applicant = BIOMET, INC.
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