FDA recall Z-2261-2018

Product

P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.

Reason for recall

Missing drill guide as stated in the package.

Distribution

Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, VA, WA, and WI; to countries of: Australia and South Africa.

Key facts

Status

Terminated

Initiation date

2017-12-19

Report date

2018-06-27

Termination date

2021-01-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Englewood, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2261-2018