Product Description
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use.
Catalog Number: 5521-B-200
Reason for Recall
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
Action Details
Stryker issued Urgent Medical Device Recall (UMDR) PFA 3554908 by third party Sedgwick on September 04, 2024, via UPS 2-day air. 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 (Table 1).
4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form:
" Medical Facility: Please sign the Business Reply Form and email to:
strykerortho8441@sedgwick.com/ Fax: (800) 871-7417
" 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 3554908 Please add the tracking number
Please assist us in meeting our regulatory obligation by completing and emailing 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 (201) 831-5000. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
Distribution Pattern
US Nationwide distribution in the states of AZ, FL, NC, OH, PA, TN, WI.
Stryker issued Urgent Medical Device Recall (UMDR) PFA 3554908 by third party Sedgwick on September 04, 2024, via UPS 2-day air. 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 (Table 1).
4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form:
" Medical Facility: Please sign the Business Reply Form and email to:
strykerortho8441@sedgwick.com/ Fax: (800) 871-7417
" 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 3554908 Please add the tracking number
Please assist us in meeting our regulatory obligation by completing and emailing 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 (201) 831-5000. For questions pertaining to the recall, email SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com
Code Information / Serial Numbers
UDI-DI: 07613327026306
Lot numbers: LZX4LB, OLH7VA
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.