—#206593

Product

TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-64H

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K171768
Affected lot / code info: UDI-DI: (01)07613327380927(17)290313(10) Lot Number: 15611151

Why it was recalled

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Stryker 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

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK

Timeline

Recall initiated: 2024-02-27
Posted by FDA: 2024-04-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206593. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.