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

• Date Initiated by Firm: June 16, 2017
• Create Date: December 20, 2017
• Recall Status: Terminated 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: 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