Medical device maker Stryker Corporation is recalling 16,992 orthopedic implant devices because of the potential of damage during shipping caused by a packaging problem.
According to the US Food and Drug Administration (FDA) notice, 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 FDA notice includes the part and lot numbers of all affected devices.
It notes that the integrity of the packaging “may potentially be compromised in transportation,” which could damage the product.
“There have been no reported adverse events related to this lot-specific voluntary recall,” Jeanine Guilfoyle, senior public relations manager, Stryker Orthopedics, told Medscape Medical News. “With the product quarantined as a result of a product hold placed in February 2015, limited field impact was expected.”