FDA recall Z-2405-2023
Conformis, Inc. · Class II · device
Product
CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
Reason for recall
30mm screws were labeled as 25mm screws.
Distribution
US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-06-16
- Report date
- 2023-08-23
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Billerica, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2405-2023