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U.S. Department of Health and Human Services

Class 2 Device Recall RingLoc ArComXL Highly Crosslinked Polyethylene Liners

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  Class 2 Device Recall RingLoc ArComXL Highly Crosslinked Polyethylene Liners see related information
Date Initiated by Firm December 19, 2016
Create Date January 13, 2017
Recall Status1 Terminated 3 on September 19, 2017
Recall Number Z-1024-2017
Recall Event ID 75970
510(K)Number K110555  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product RingLoc ArComXL Highly Crosslinked Polyethylene Liners
ArComXL High Wall +3mm Liners Size 23 item XL-108323
ArComXL MaxRom +3mm Liners Size 23 item XL-108223
Code Information Item XL-108323, Lot 761680, UDI (01)00880304651524(17)210713(10)761680

Item XL-108223, Lot 419460, UDI (01)00880304651494(17)210713(10)419460
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Customer Service
800-348-2759
Manufacturer Reason
for Recall
Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.
FDA Determined
Cause 2
Under Investigation by firm
Action Zimmer Biomet sent an Urgent Medical Device Recall (REMOVAL)  LOT SPECIFIC notifications dated December 19, 2016, to the affected distributors and Risk Managers and Distributors via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Risk Manager Responsibilities: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative quarantine all affected product. 3. Your Zimmer Biomet sales representative will remove the affected product from your facility. 4. Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com. b. Retain a copy of the Acknowledgement Form with your recall records in the event of a compliance audit of your facilities documentation. 5. If after reviewing this notice you have further questions or concerns please call 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to corporatequality.postmarket@zimmerbiomet.com. Distributor Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification
Quantity in Commerce 36
Distribution USA (nationwide) and Internationally to ARGENTINA
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = BIOMET MANUFACTURING CORP.
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