Stryker Howmedica Osteonics Corp. is voluntarily recalling 16, 992 elbow devices because of the potential of damage during shipping caused by a packaging problem.
According to an August 20, 2015 Food and Drug Administration (FDA) notice, the recall includes five devices: the rHead lateral stem and Recon radial implant, both for replacement of the proximal end of the forearm’s radius bone; the uHead ulnar implant and Sigmoid Notch radial plate, both for replacement of the distal radioulnar joint; and the Radio-Capitellum to improve elbow function.
The FDA notice includes the part and lot numbers of all affected devices.
“There have been no reported adverse events related to this lot-specific voluntary recall, ” Jeanine Guilfoyle, senior public relations manager, Stryker Orthopedics, told Medscape Medical News. “With the product quarantined as a result of a product hold placed in February 2015, limited field impact was expected.”
This is a class 2 recall, which is defined by the FDA as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The products were manufactured in Stryker’s Mahwah, New Jersey, plant and were distributed worldwide.
Stryker has notified customers of the recall by e-mail and an urgent medical device removal letter/acknowledgement response form. Customers were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.
“All affected customer locations have been notified, the majority of which includes locations with product prior to Stryker’s acquisition of Small Bone Innovations, Inc. (SBi) assets in August 2014. This voluntary recall is reflective of our continued commitment to quality in all of our products and services, ” Guilfoyle said.
For more information, customers may contact Paul Jahnke at 201-831-5826.
