—#208515

Product

UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038

FDA product code: KWL — Prosthesis, Hip, Hemi-, Femoral, Metal
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K014226
Affected lot / code info: GTIN: 07613327032338 Lot Numbers: JT38AD, E94VEV

Why it was recalled

Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

Root cause (FDA determination)

Employee error

Action the firm took

Stryker issued Urgent Medical Device Recall (UMDR) PFA 3585464 third party Sedgwick on June 19, 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: strykerortho6601@sedgwick.com/ Fax: (844) 441-2737 " 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 3585464 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

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, and UK.

Timeline

Recall initiated: 2024-06-19
Posted by FDA: 2024-07-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208515. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.