FDA recall Z-1676-2020

Synvasive Technology Inc · Class II · device

Product

ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures. Manufactured By: Synvasive Technology, Inc., a Subsidiary of Zimmer

Reason for recall

Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm.

Distribution

US distribution to states of AL and NY

Key facts

Status
Terminated
Initiation date
2018-07-27
Report date
2020-04-15
Termination date
2021-06-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
El Dorado Hills, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1676-2020