Class 2 Device Recall Stryker

• Date Initiated by Firm: January 14, 2022
• Create Date: March 31, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0843-2022
• Recall Event ID: 89592
• 510(K)Number: K052718
• Product Classification: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
• Product: Biolox delta Ceramic V40 Femoral Head 32/ +4.0mm Catalog Number: 6570-0-232
• Code Information: Lot Number: 89546202 GTIN: (01)04546540608536(17)261020(10)89546202
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: Loriann Russo Stryker; 201-831-5000
• Manufacturer Reason for Recall: Potential product mix where the size and/or offset of the Biolox delta Ceramic V40 Femoral Head inside the package does not match the package labeling
• FDA Determined Cause: Under Investigation by firm
• Action: Stryker issued Urgent Medical Device Recall (UMDR) PFA 2902313 on 14th January 2022 to affected consignees. Letter states reason for recall, health risk and action to take: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 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. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and email to strykerortho2798@sedgwick.com / Fax: (866) 915-5064. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 6. Please return the devices back to Stryker using the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07430 Ref. PFA 2902313 Please assist us in meeting our regulatory obligation by emailing back the attached Urgent Medical Device Recall Business Reply Form within 5 days. A response is required, even though you may not have any physical inventory on site. ****UPDATE 3/17/22: Urgent Medical Device Recall UPDATE issued on March 15, 2022, impacts consignees in the following countries due to the change in scope: U.S., Canada, China, Japan, UK, and Netherlands. However, consignees in Ireland, Spain, Germany, and Belgium, who originally received the UMDR, will also be notified of the UMDR UPDATE so they are made aware that they did not receive product that was non-conforming. UMDR UPDATE issued on March 15, 2022: 1. Please inform users of this Urgent Medical Device Recall UPDATE and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately che
• Quantity in Commerce: 39 units Updated: 40 units
• Distribution: Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, MD, MN, NC, NJ, NY, OH, OR, PA, TN, TX and the countries of Canada, China, Japan, Spain, UK, Netherlands, Germany & Belgium. ***Updated 3/17/22: U.S., Canada, China, Japan, UK, and Netherlands.
• 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 = LZO and Original Applicant = HOWMEDICA OSTEONICS CORP