Class 2 Device Recall Stryker

• Date Initiated by Firm: December 22, 2023
• Date Posted: February 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1000-2024
• Recall Event ID: 93830
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: HRIS ACET CUP CUT TIP 32X140 ; Part Number: 6210-5-200rker. ; single-use, sterile surgical instruments used during hip arthroplasty
• Code Information: GTIN: 07613327144093 Lot Numbers: X22H11A1 X22H11 X22E19A X22E19D X22E19 X22C19 X22C19A1 X22C19A2 X22C19A3 X21M16A X21M16 X21K12 X21K12A X20T14A1 X20P04D X20P04A X20T14A2 X20P04 X20T14 X19P17 X19P05 X19M57 X19M55D X19M55A X19M55 X19D04A X19D03 X19D04 X18T45 X18S06A X18S06 X18S06D X18N50 X18E19KA X17V14D X17V14A X18E09A X18E09 X18E19KAA1 X18E19KAA2 X17T14 X17T13 X17T14A X17K16 X17L31 X16W10 X16V16 X16V41 X16V29 X16M13 X16L13 X16L12 X16H32 X16H19 X16E12 X16C06 X16A07 X15V08 X15V08A X15N27 X15M06 X15L22 X15L03 X9K29 X15E23 X15E22 X15A04 X9V15 X9S15 X9N52E X9N52 X9N13 X9K06 X9L11 X9E25A X9E25D X9C05 X9C05Y X8L03 X8L03A X7M04 X7M07A X7M07M X7M07 X7M06 X7M04A X7H21TD X7H21T X7H23 X7K17 X7H21 X7H27 X7H27A X7A13P X7A13 X7A13PA X5T77 X5M46 X5M46L X5H43A X5H43 X5M47E X5M47T X5M47 X5L45 X5E50
• 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: Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
• FDA Determined Cause: Package design/selection
• Action: Stryker issued Urgent Medical Device Recall (UMDR) PFA 3285098 was issued by third party Sedgwick on 22/DEC/2023 via UPS 2-day air. OUS customer notification will be issued at the country level. Letter states reason for recall, health risk 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. 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. Dispose of all affected products listed in the Part and Lot Number Attachment (PFA 3285098). 4. Complete and sign the enclosed Urgent Medical Device Correction Business Reply Form. " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4742@sedgwick.com / Fax: (866) 723-2482 " Stryker Branch/Agency: please sign the AdobeSign form arriving to you via email. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions. 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. If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the correction, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
• Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Brazil, Canada, Chile, China (Hong Kong), Columbia, Italy, Japan, Malaysia, Netherlands (Venlo), Slovenia, S. Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
• 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.