In late August of 2015 Stryker recalled nearly 17,000 arm implant devices because their packaging could be compromised while being transported. Namely, for 16,992 units of five orthopedic devices of the arm, the sterile barrier of the packaging could be compromised, noted the U.S. Food and Drug Administration.
Five Forearm Implant Devices Recalled
The five Stryker implant devices recalled are the Recon radial implant and rHead lateral stem, both designed for replacement of the proximal end of the radius bone of the forearm, the Sigmoid Notch radial plate and the uHead ulnar implant, both designed for replacement of the forearm’s distal radioulnar joint between the forearm’s two bones, and the Radio-Capitellum, designed to enhance elbow function.
Customers impacted by the voluntary Stryker recall were alerted by email and by a medical device removal letter in late June. Stryker claims that no adverse events have been reported in relation to the recall.
Stryker acquired each of these devices in 2014 as part of its $375 million purchase of Small Bone Innovations. The five devices were manufactured in Mahwah, NJ, by Stryker Howmedica Osteonics, for distribution worldwide.
Class 2 Recall Parameters
This was a Class 2 recall, as designated by the FDA. Class 2 recalls involve situations 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.”
A Class 2 recall is the second-most serious recall classification given by the FDA, whose recall notice also included lot and part numbers of the targeted devices.
With headquarters in Kalamazoo, Michigan, Stryker Corp. has around $9 billion in annual revenue. Subsidiary Stryker Orthopaedics controls almost 25% of the knee and hip implant market in the United States and is considered the nation’s second-largest seller of orthopaedic devices — and is among the world’s 15 most profitable orthopaedic and spine device companies, focusing on knee, hip, shoulder and bone products.
However, massive hip implant recalls had to be issued in 2012. Indeed, there have been hundreds of Stryker injury lawsuits since the recall was issued.
Stryker Hip, Knee Implants Also Recalled
Among Stryker recalls for defective medical devices was an FDA recall issued for parts made for the socket section of Stryker hip implants in 2008. Also, in 2012 the FDA issued a Stryker recall for the Rejuvenate Modular Hip System, which includes the Rejuvenate Modular and ABG II modular-neck hip stems.
Stryker hip implant recalls involved new metal-on-metal hip implants which sometimes failed within a few months of hip replacement surgery. Though such devices were supposed to endure for up to 20 years, many failed by grinding away tiny shards of toxic metal which then became embedded in tissues and bone, causing pain, inflammation and loss of mobility.
Then a follow-up implant surgery was needed, also known as replacement surgery, to replace the defective hip replacement.
Stryker also has been known to make defective knee implants. The FDA warned Stryker that components of two knee implants, the Scorpio and Duracon, were not conforming to manufacturing standards. Stryker then recalled one knee implant system
and parts of others.
Stryker Implant Lawsuits
If a member of your family has been injured by a defective Stryker forearm implant or other medical device, notify the defective medical device attorneys at Jim Adler & Associates for your free case review. You could be legally entitled to significant financial compensation for your losses, which could come with a Stryker implant lawsuit.