FDA Class 2 Recall for 17,000 Stryker Orthopedic Devices Possibly Damaged in ShippingAug 28, 2015
The Food and Drug Administration (FDA) has issued an announcement of the recall of 16,992 Stryker Corporation orthopedic implant devices because of potential damage during shipping.
The recall 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 the devices affected by the recall. According to the FDA, the integrity of the products' packaging "may potentially be compromised in transportation," which could result in damage to the product. Jeanine Guilfoyle, senior public relations manager for Stryker Orthopedics, said, "There have been no reported adverse events related to this lot-specific voluntary recall." Medscape reports that Stryker expected "limited field impact" because the product was quarantined as a result of a product hold placed in February 2015.
This is a Class 2 recall, which is the FDA's intermediate device recall category. In a Class 2 recall, "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 covers a total of 16,992 devices manufactured by Stryker Howmedica Osteonics of Mahwah, New Jersey. The devices were distributed worldwide. Stryker notified customers by email and through 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.
Customers needing further information may contact Stryker's Paul Jahnke at 201-831-5826. The FDA encourages health care professionals and patients who experience 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: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; by fax at 1-800-FDA-0178; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.