FDA recall Z-2087-2019

Product

Maximum Pelvic Trainer (MPT)

Reason for recall

The device was incorrectly listed with the FDA and is therefore considered adulterated and misbranded if left on the market. Additionally, the firm did not submit a 510k for the device.

Distribution

Nationwide distribution 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, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and PR.

Key facts

Status

Terminated

Initiation date

2019-07-12

Report date

2019-08-07

Termination date

2022-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Selma, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2087-2019