FDA-Device2014-11-19Class II
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
DePuy Orthopaedics, Inc.
Hazard
Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.
Sold states
Worldwide Distribution - USA (nationwide) except AK, including Puerto Rico and the countries of Canada, Australia, Austria, Belgium, China, France, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, UAE, United Kingdom and Chile.
Affected count
3,082
Manufactured in
700 Orthopaedic Dr, Warsaw, IN, United States
Products
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0199-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief