FDA recall Z-0626-2024
Encore Medical, LP · Class II · device
Product
REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
Reason for recall
Mislabeling
Distribution
US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
Key facts
- Status
- Completed
- Initiation date
- 2023-10-05
- Report date
- 2024-01-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Austin, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0626-2024