FDA recall Z-0435-2021
Merete Medical GmbH · Class II · device
Product
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
Reason for recall
Product may be mislabeled.
Distribution
Product was distributed in US - CA, IL, MD, OH, and NJ
Key facts
- Status
- Terminated
- Initiation date
- 2020-09-18
- Report date
- 2020-11-18
- Termination date
- 2021-05-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Berlin, Germany
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0435-2021