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U.S. Department of Health and Human Services

Class 2 Device Recall RingLoc Acetabular Shells

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  Class 2 Device Recall RingLoc Acetabular Shells see related information
Date Initiated by Firm June 29, 2017
Create Date January 04, 2018
Recall Status1 Open3, Classified
Recall Number Z-0312-2018
Recall Event ID 78758
510(K)Number K093235  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62

The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended for uncemented use only.
Code Information Model No. 11-116062, Lot No. 374670, UDI No. (01) 0 0880304 59316 9 (17) 270513 (10) 374670
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-371-3071
Manufacturer Reason
for Recall
Device was distributed with the etching missing from the product.
FDA Determined
Cause 2
Employee error
Action The firm, Zimmer Biomet, sent an, "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated 6/28/2017 via email and FedEx on approximately 06/29/2017 to its consignees. The letter described the product, problem and actions to be taken. The consignees were Instructed to ensure appropriate personnel are notified, immediately locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement form by email to:corporatequality.postmarket@zimmerbiomet.com or fax to: 574-372-4265, return all affected products, and provide the names of any locations where product was further distributed to. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-574-371-3071 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.
Quantity in Commerce 15 units
Distribution Distributed domestically to MI, MN, ND.
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 = LPH and Original Applicant = BIOMET, INC.
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