FDA-Device2016-06-15Class II
Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
Synthes (USA) Products LLC
Hazard
DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.
Sold states
Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada...
Affected count
2812 units
Manufactured in
1301 Goshen Pkwy, N/A, West Chester, PA, United States
Products
Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1943-2016Don't want to check this manually?
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