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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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 Class 2 Device Recall Strykersee related information
Date Initiated by FirmDecember 22, 2023
Date PostedFebruary 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0999-2024
Recall Event ID 93830
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductHRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Code Information GTIN: 07613327144086 Lot NUmbers: X22V12 X22V12A X22V12D X22T13A X22T13 X22T13D X22M09D X22M09 X22M09A X21T01K X21T01M X21T01 X20T19 X20T17A X21E23E X21E23D X21E23 X21E23A X20T17 X20T19M X20C37 X20C03A X20C03 X19N44 X19M03A X19M03 X19M02 X19K25A X19K25 X19K24 X19T10 X19K01A X19K01 X19K01D X18S14A X18T28A X18T28 X18T28A1 X18S14D X18N49 X18S14 X17N33R X18C24 X18E04 X18E04A X17N33 X17N33D X17N33A X17L11 X17L11D X17L11A X16T27 X16V17 X16W06 X16W08 X16H36 X16H37A X16H37 X16E15J X16E15K X16C22 X16A06 X15V17 X15V17A X15S26 X15S26A X15M17A X15M17 X15N14A X15N14J X15L12 X15H18 X15K15 X9W16 X9W16E X9V09 X9N60M X9T20 X9T20A X9S16 X9N60P X9N25 X9N29 X9L15J X9K31 X9K09 X9E24 X9A03A X9A03 X9A03D X9A03E X8T01 X8T01A X8L28TT X8L28T X8L28 X8L28A X7M11 X7H42A X7M22 X7M11M X7K10 X7H42 X5E15 X5M45V X5T70 X5M45K X5M45 X5M45L X5H45A X5H45 X5H12 X5H12D X5L22 X5L22W X5L22W1 X5C35
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactSAME
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 2		Package design/selection
ActionStryker 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
DistributionWorldwide 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 CycleTPLC 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.
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