FDA-Device2014-01-22Class II
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Biomet, Inc.
Hazard
3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
Sold states
US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
Affected count
52
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0716-2014Don't want to check this manually?
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