Stryker (NYSE:SYK) is recalling 16,992 orthopedic implant devices in an FDA Class II recall due to possible packaging compromises during transportation
The Class II label indicates that the device could create “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,” according to the federal watchdog.
The units come from 5 different lines of products, with the FDA indicating the rHead, uHead, Sigmoid Notch, Remotion and Radio Capitellum devices for the recall.
Stryker began notifying customers in June of the issue, according to the FDA filing. The devices were distributed worldwide.
The devices come from Small Bone Innovations, who Stryker purchased last October for $375 million.
The FDA posted a full list of the lot numbers and information on the recalled devices in their filing on the recall.
