FDA recall Z-0406-2018

Smith & Nephew, Inc. · Class II · device

Product

Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.

Reason for recall

The expiration date provided on the label is incorrect.

Distribution

Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.

Key facts

Status
Terminated
Initiation date
2017-10-23
Report date
2018-01-31
Termination date
2018-08-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0406-2018