09.15.15
Kalamazoo, Mich.-based Stryker Corp. is recalling 16,992 orthopedic implants due to the potential of damage during shipping caused by flawed packaging.
The recall notice from the U.S. Food and Drug Administration (FDA) includes five devices: the rHead lateral stem and Recon radial implant (both used to replace the proximal end of the forearm’s radius bone); the uHead ulnar implant and Sigmoid Notch radial plate (used to replace the distal radioulnar joint); and the Radio-Capitellum for the elbow. Stryker acquired the devices last year as part of its purchase of Small Bone Innovations.
The recall was designated as 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 recall was initiated, according to the FDA, “because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.” Stryker has notified customers of the recall by e-mail and an urgent medical device removal letter/acknowledgement response form. A company spokesperson said there have been no adverse events related to the recall.
The products were manufactured at Stryker’s facility in Mahwah, N.J.
The recall notice from the U.S. Food and Drug Administration (FDA) includes five devices: the rHead lateral stem and Recon radial implant (both used to replace the proximal end of the forearm’s radius bone); the uHead ulnar implant and Sigmoid Notch radial plate (used to replace the distal radioulnar joint); and the Radio-Capitellum for the elbow. Stryker acquired the devices last year as part of its purchase of Small Bone Innovations.
The recall was designated as 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 recall was initiated, according to the FDA, “because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.” Stryker has notified customers of the recall by e-mail and an urgent medical device removal letter/acknowledgement response form. A company spokesperson said there have been no adverse events related to the recall.
The products were manufactured at Stryker’s facility in Mahwah, N.J.