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U.S. Department of Health and Human Services

Class 2 Device Recall Prosthesis Shoulder Hemi Humeral Metallic Uncemented. ExploR, ExploR Radial Head

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  Class 2 Device Recall Prosthesis Shoulder Hemi Humeral Metallic Uncemented. ExploR, ExploR Radial Head see related information
Date Initiated by Firm June 16, 2017
Create Date December 20, 2017
Recall Status1 Terminated 3 on September 06, 2018
Recall Number Z-0269-2018
Recall Event ID 78705
510(K)Number K051385  
Product Classification Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
Product ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610.

The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for protection. The inner tray and the contents within will then have a Tyvek¿ lid heat sealed to the tray. The sealed inner tray will be fit into an outer PETG tray and a Tyvek¿ lid heat sealed to the tray. The entire sealed unit is placed in a SBS carton that will be shrink wrapped for protection.
Code Information Part Lot UDI Number 11-210061 243610 and 202900; (01)00880304210448(17)260817(10)243610 
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		 Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.
FDA Determined
Cause 2		 Packaging change control
Action Zimmer Biomet sent US Fiedl action notices 6/16/17 via email and fed Ex. On 9/5/17, firm expanded their recall to include 1 lot and distributed Amended notices via email and FedEx
Distribution US, Canada, OUS.
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 = KWI and Original Applicant = BIOMET, INC.
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