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U.S. Department of Health and Human Services

Class 2 Device Recall Hard Tissue Replacement Implants

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  Class 2 Device Recall Hard Tissue Replacement Implants see related information
Date Initiated by Firm June 13, 2016
Create Date September 08, 2016
Recall Status1 Terminated 3 on August 21, 2019
Recall Number Z-2751-2016
Recall Event ID 74798
510(K)Number K924935  
Product Classification Material, polytetrafluoroethylene vitreous carbon, for maxillofacial reconstruction - Product Code KKY
Product Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made.
HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
Code Information Custom made, one per customer. Affected units were sealed between April 28, 2016 and June 7, 2016
Recalling Firm/
Manufacturer		 Biomet Microfixation, LLC
1520 Tradeport Dr
Jacksonville FL 32218-2480
For Additional Information Contact Jay Sharma
904-741-9225
Manufacturer Reason
for Recall		 Potential sterility deficiency.
FDA Determined
Cause 2		 Packaging
Action Zimmer Biomet Customers were sent an Urgent Product Recall letter dated June 13, 2016, via via FedEx mail. The letter notified customers of a recall of Hard Tissue Replacement Polymer Implants due to voids in sterile packaging. The firm instructed customers to locate and discontinue use of the implants, complete the Fax Response form and fax it to 904-741-9425, send back any quarantined product using the FedEx labels provided along with the recall notification, and to notify facilities where the implant was further distributed by forwarding them a copy of the provided notice. The firm instructed distributors to forward the notice to officials of their customers who are in charge of receiving recall notices. Additionally, the firm informed distributors that they are responsible for locating and returning distributed product. Questions are to be directed to 1-800-874-7711 or 904-741-4400 x9574, Monday thru Friday from 8am to 4pm ET. Her after hours phone is 812-614-9499. For questions regarding this recall call 904-741-9225.
Quantity in Commerce 54 units
Distribution Worldwide Distribution - US including AZ, CA, FL, MO, NH, PA, TX, & VA, and Internationally to Austria, Canada, England, Germany, Greece, Italy, Netherlands, & South Africa.
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 = KKY and Original Applicant = POLYCLINIC MEDICAL CENTER
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