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U.S. Department of Health and Human Services

Class 2 Device Recall Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small

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  Class 2 Device Recall Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small see related information
Date Initiated by Firm August 16, 2016
Date Posted September 08, 2016
Recall Status1 Terminated 3 on June 12, 2017
Recall Number Z-2752-2016
Recall Event ID 74930
510(K)Number K001989  
Product Classification Prosthesis, elbow, constrained, cemented - Product Code JDC
Product Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the outer cavity. The patient record label is placed on the Tyvek outerlid. The sealed cavities and package insert is placed into a folding carton, sealed and shrink wrapped.
Total elbow prosthesis designed for use with bone cement
Code Information Item Number: 32-8105-027-01 Lot Number: 62811341
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Customer Service
877-946-2761
Manufacturer Reason
for Recall
Zimmer Biomet is conducting a voluntary medical device recall of a single lot of the Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small because the lot was packaged with a missing humeral bushing. The missing bushing could result in a surgical delay or additional surgery if a replacement is not available.
FDA Determined
Cause 2
Process design
Action Zimmer Biomet sent an Urgent Medical Device Recall Removal letter dated August 16, 2016, for their C/M Elbow Pin/ Bushing Replacement Kit via FedEx. All distributors were notified via electronic mail. Hospital risk managers, as well as distributors with product, were notified via courier. Customers were instructed to complete the following items including locating and removing the product in their territory, as well as identifying hospitals that currently have the affected product. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers were provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Attachment 1 form. - Complete and return Attachment 1 (Acknowledgement of Responsibility) to the fax number or email address provided. If there are questions or concerns please call the customer call center at 1-800-348-9500 ext 1251 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 CPWARFieldAction@zimmerbiomet.com. For questions regarding this recall call 877-946-2761.
Quantity in Commerce 25 units
Distribution Worldwide Distribution - US including AL, AZ, CA, CT, GA, MN, NC, OH, OR and Internationally to Australia, Germany, Japan, Korea, and Taiwan.
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 = JDC and Original Applicant = ZIMMER, INC.
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