Class 3 Device Recall SIMPLEX P Radiopaque Bone Cement

• Date Initiated by Firm: November 07, 2022
• Date Posted: December 20, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0736-2023
• Recall Event ID: 91147
• 510(K)Number: K002652
• Product Classification: Bone cement - Product Code LOD
• Product: Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
• Code Information: UDI# P/N 6191-0-001 (01)07613327128772 (17)261031(10)lot# GTIN: 07613327128772 -Instructions for Use (IFU) received with product: 0700-7-010 (IFU Radiopaque Bone Cement) All lots manufactured under Rev AB, with Exp. Date on/after September 16, 2021.
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: Loriann Russo; 201-831-5000
• Manufacturer Reason for Recall: Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.
• FDA Determined Cause: Under Investigation by firm
• Action: Update 12/15/22: An UPDATED Urgent Medical Device Correction PFA 3140774 was issued to impacted customers in Turkey only on December 15, 2022. Letter states: 1. Please inform users of this UPDATE Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware. 2. Go to link https://ifu.stryker.com/ and follow instructions for Figures 1 and 2 for the electronic version of the Turkish translated Instructions for Use for affected product outlined in Table 1. 3. Complete and sign the enclosed UPDATE Urgent Medical Device Correction Business Reply Form. Potential Harm: There are no identified harms associated with this issue which would lead to any known adverse health consequences. Please assist us in meeting our regulatory obligation by emailing back the attached UPDATE Urgent Medical Device Correction Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com. ____________________________________________________________________________ Stryker issued Urgent Medical Device Correction PFA 3140774 to customers in Turkey only via Stryker sales representatives on Nov. 16, 2022. Letter states reason for recall and action to take: 1. Please inform users of this Urgent Medical Device Correction and forward this notice to all individuals who need to be made aware. 2. Go to link https://ifu.stryker.com/ and follow instructions for Figures 1 and 2 for the electronic version of the Turkish translated Instructions for Use for affected product outlined in Table 1. 3. Complete and sign the enclosed Urgent Medical Device Correction Business Reply Form.
• Quantity in Commerce: 2085 units
• Distribution: International distribution in the country of Turkey.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LOD