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 Reconradial implant, both for replacement of the proximal end of the forearm’s radius bone; the uHead ulnar implant and Sigmoid Notchradial 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.”
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 products 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 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. This voluntary recall is reflective of our continued commitment to quality in all of our products and services,” Guilfoyle said.
For more information, customers may contact Paul Jahnke at 201-831-5826.
Healthcare professionals are encouraged to report adverse events or adverse effects related to the use of these products to MedWatch, the FDA’s safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.