—#188610

Product

Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K141056
Affected lot / code info: Lot JHS2H

Why it was recalled

The internal profile of the Triathlon Prim (Baseplate) is potentially oversized; there may be a witness mark (taper) at the bottom of the internal profile of the baseplate, which prevents the insert from locking on the baseplate.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On July 1, 2021, the firm notified customers via Urgent Medical Device Recall. The letter listed the hazards and harms potentially associated with the recalled product and also listed mitigation factors. Patients treated with an affected product should continue to be followed per the normal protocol established by his or her surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol. It should be noted that the failure of the insert to fully seat, may not be evident on x-ray unless the insert has dislodged. Actions Needed: Our records indicate that you may have received the affected product(s). It is Strykers responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important follow up communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 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. Return the devices back to Stryker. Customers should complete and sign the included customer response form and return it to the recalling firm. Hospitals should contact their local sales office or Stryker sales representative directly for product returns and inventory questions. Customers who have further distributed the product should forward should notify downstream accounts and return all affected devices to the recalling firm. For questions pertaining to the recall, please contact Customer Service at (201) 831-5000, or 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 distribution in the states AR, CO, MN, MS, NJ, OK, PA, TX and the countries of China and Italy.

Timeline

Recall initiated: 2021-07-01
Terminated: 2023-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188610. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.