ClearanceBrief
Recall Z-1468-2019 ยท HTW Bit, Drill

Zimmer GmbH

Drill for 2.7mm screw, 20mm stop, 2x105mm, Stryker, Item Number ST502015206

DateApr 8, 2019
StatusTerminated
ReasonAn investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Root causeUnder Investigation by firm
ActionUrgent Medical Device Recall notification letters dated 4/8/19 were sent to customers.
DistributionThe products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.