Stryker Recalls 17,000 Orthopedic Devices Due to Possible Damage in Shipping

Stryker Corporation has recalled nearly 17,000 orthopedic implant devices because of potential damage during shipping.

The recall notice posted by the Food and Drug Administration (FDA) 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 part and lot numbers of all affected devices are listed in the FDA notice. The FDA explains that the integrity of the products’ packaging “may potentially be compromised in transportation,” and this could damage the product. According to Jeanine Guilfoyle, senior public relations manager for Stryker Orthopedics, “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, “limited field impact was expected,” Medscape reports. A total of 16,992 devices manufactured by Stryker Howmedica Osteonics of Mahwah, New Jersey were recalled. The devices were distributed worldwide.

This is a Class 2 recall, the FDA’s intermediate device recall category. Class 2 is for 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.”

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 may contact Stryker’s Paul Jahnke at 201-831-5826 for further information. 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 (https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm), by fax to 1-800-FDA-0178; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.

 

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