Class 2 Device Recall Stryker Orthopaedics

• Date Initiated by Firm: November 07, 2019
• Create Date: January 15, 2020
• Recall Status: Terminated on August 31, 2020
• Recall Number: Z-0811-2020
• Recall Event ID: 84346
• 510(K)Number: K974685
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
• Product: Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum ; Catalog #: 2041C-3254
• Code Information: Lot Number: 53778501 UDIs: (01)04546540035806(17)201108(10)53778501
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: SAME; 201-831-5000
• Manufacturer Reason for Recall: May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire
• FDA Determined Cause: Employee error
• Action: Stryker issued Urgent Medical Device Recall - PFA 2147264 letter dated November 7, 2019) to US consignees by third-party recall company, Stericycle Inc. (2670 Executive Drive Indianapolis, IN 46241), via UPS 2nd day air. Letter states reason for recall, health risk and action to take: Actions Needed: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3.Quarantine and discontinue use of the recalled devices. 4.Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-888-350-3903 or email to StrykerOrtho6467@stericycle.com within 5 Days. 5.Hospitals Only: Return all affected product available at your location to your local branch office. 6.Branches/Agencies: Return all affected product returned by the hospital and/or available at your location to the following address: Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team 325 Corporate Drive, Dock M-East, Mahwah, NJ 07430, PFA #2147264. Actions Needed: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization.2.Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3.Quarantine and discontinue use of the recalled devices. 4.Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to
• Quantity in Commerce: 20 units
• Distribution: CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan
• 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 = JDI and Original Applicant = OSTEONICS CORP.