# FDA recall Z-0023-2025

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2024-09-04.

## Product

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.

## Distribution

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. 

## Key facts

- **Recall number:** Z-0023-2025
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-04
- **Report date:** 2024-10-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0023-2025

## Citation

> AI Analytics. FDA recall Z-0023-2025. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-0023-2025. Source: US FDA. Licensed CC0.

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