Medical device maker Stryker Corporation is recalling nearly 17,000 orthopedic implant devices because of potential of damage during shipping.
The Food and Drug Administration (FDA) notice lists five devices included in the recall: 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, Medscape reports. The FDA notice contains the part and lot numbers of all affected devices. It notes that the integrity of the packaging “may potentially be compromised in transportation,” and this could damage the product. Jeanine Guilfoyle, senior public relations manager for Stryker Orthopedics, told Medscape, “There have been no reported adverse events related to this lot-specific voluntary recall.” Because the product was quarantined as a result of a product hold placed in February 2015, Guilfoyle said “limited field impact was expected.”
The recall was designated as a Class 2 recall, which is the intermediate of the FDA’s three recall classes and is applied to 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.”
The 16,992 recalled devices were manufactured in Mahwah, New Jersey, by Stryker Howmedica Osteonics and were distributed worldwide.
Stryker has notified customers of the recall by e-mail and with an urgent medical device removal letter/acknowledgement response form. “All affected customer locations have been notified, the majority of which includes locations with product prior to Stryker’s acquisition of Small Bone Innovations, Inc. (SBi) assets in August 2014,” Guilfoyle said.
For further information, customers may contact Paul Jahnke at 201-831-5826. The FDA encourages health care professionals to report adverse events related to the use of these products to MedWatch, the FDA’s safety information and adverse event reporting program: www.fda.gov/MedWatch/report. Reports may be submitted online, by fax at 1-800-FDA-0178; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.