Recall Z-2308-2026
- Recall number
- Z-2308-2026
- Event number
- 98773
- Firm
- Grace Medical, Inc.
- Firm FEI
- 1000022662
- Product code
- ETB
- Status
- Open, Classified
- Initiated
- 2026-04-03
- Posted
- 2026-06-04
- Root cause
- Process control
- 510(k) numbers
- K060518, K823483, K061853, K013573, K981045, K945107, K972492, K915121, K001142, K950885, K954517, K241142, K832540, K993234, K950984, K952481, K964798, K823439, K950886, K925443, K260718, K992839, K893134, K913285, K080070, K945108, K963752, K945105, K802873, K945104
Product#
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Reason for Recall#
Due to incorrect functional length on device labeling.