Stryker Corporation, a medical device maker, has issued a voluntary recall of orthopedic implants because of potential damage to the device during the shipping process. The issue involves the packaging of the device that has been improperly designed.
About the Defective Orthopedic Implants
According to the Food and Drug Administration (FDA), the recall involves 16,992 orthopedic implants. The FDA has issued statements involving the integrity of the packaging which can greatly damage the device rendering it useless and even dangerous.
Medscape Medical News, reports that the Stryker Corporation has quarantined the product due to a hold that was put in place in February 2015.
The FDA has also stated that the case is a class 2 recall. This means that the use of or exposure of the violative product can cause temporary or medically reversible adverse health consequences.
Description of the Recalled Implants
All the following information was provided by Medscape Medical News:
- 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 products were manufactured in Mahwah, New Jersey, by Stryker Howmedica Osteonics and were distributed worldwide.
- Healthcare professionals are encouraged to report adverse events or adverse effects related to the use of these products to MedWatch, the FDA’s safety information and adverse event reporting program.