Stryker Recalls More than 16,000 Orthopedic Implants
Stryker Medical is recalling 16,992 units of five orthopedic implants because the packaging’s sterile barrier may be compromised during transportation.
The five devices are the rHead lateral stem, the Recon radial implant, the uHead ulnar implant, the Sigmoid Notch radial plate and the Radio-Capitellum.
Stryker notified customers of the recall in June via email and an Urgent Medical Device Removal Letter. The FDA designated the recall Class 2.
Stryker acquired the devices last year when it bought Small Bone Innovations for up to $375 million. The devices were manufactured at the company’s Mahwah, N.J. Howmedica Osteonics subsidiary and distributed worldwide. — Michael Cipriano