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| UNI-Elbow radio capitellum system--Courtesy of Small Bone Innovations |
Stryker ($SYK) is recalling 16,992 units of 5 orthopedic devices of the arm because their packaging might be compromised during transportation. Specifically, the packaging's sterile barrier might be affected by the problem, according to the FDA's recall database.
The 5 devices are: 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 (located between the two bones of the forearm); and the Radio-Capitellum to improve elbow function.
Stryker acquired the devices last year via its purchase of Small Bone Innovations for up to $375 million.
The recall was designated Class 2 by the FDA, reserved for 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." It is the FDA's second-most serious recall classification out of three levels.
All of the devices are distributed globally. They were manufactured in Mahwah, NJ, by Stryker Howmedica Osteonics.
Affected customers were notified via email and a medical device removal letter in late June. The FDA's recall notice also contains the part and lot numbers of all affected devices.
Stryker has been the subject of several Class 2 recalls this year, but has not had a more severe Class 1 recall since 2013, according to the FDA's database.
In general, the vast majority of all recalls or corrective actions are designated as Class 2.
- here's one of the recall notices | here's a link to all 5 of the notices