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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker TRIDENTII HEMI CLUSTER66H

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 Class 2 Device Recall Stryker TRIDENTII HEMI CLUSTER66Hsee related information
Date Initiated by FirmFebruary 27, 2024
Date PostedApril 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1627-2024
Recall Event ID 94215
510(K)NumberK171768 
Product Classification Kit, assay, estrogen receptor - Product Code LPJ
ProductTRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
Code Information UDI-DI: (01)07613327380835(17)290313(10) Lot Number: 15445252
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactLoriann Russo
201-831-5000
Manufacturer Reason
for Recall		The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
FDA Determined
Cause 2		Under Investigation by firm
ActionStryker issued Urgent Medical Device Recall (UMDR) PFA 3529813 by Sedgwick on Feb. 27, 2024, via UPS 2-day air. An OUS customer notification will also be issued at the country level. Letter states reason for recall and action to take: Technical and medical assessments are currently underway to determine any potential hazards and harms associated with the use of an impacted Trident II Acetabular Shell. An updated communication will be forwarded upon completion of the internal investigation of this issue. 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 " Medical Facility: Please sign the Business Reply Form and email to: strykerortho4091@sedgwick.com / Fax: (833) 237-1022 " 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. 6. Please return the devices 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 3529813 If you have any questions or concerns after reviewing this letter, please contact Customer Service at (888)-756-7846. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
Quantity in Commerce0
DistributionNationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
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.
510(K) Database510(K)s with Product Code = LPJ
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