—#162017

Product

radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

FDA product code: LTF — Stimulator, Salivary System
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K002644
Affected lot / code info: RHA-S1

Why it was recalled

Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On October 27, 2017 an URGENT MEDICAL RECALL NOTIFICATION was issued to customers titled Product Field Action PR 1642784. The letter requests that recipients notify all necessary individuals within their organization of the recall and that a Stryker trauma representative will collect any affected product from the customer location. Questions or concerns can be directed to 201-831-6693

Recalling firm

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

Distribution

Distribution pattern: Distribution US Nationwide.

Timeline

Recall initiated: 2017-10-24
Terminated: 2023-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.