Device product
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
Z-0437-2021
Product summary
- Event
- Event 86526
- Status
- Terminated
- Classification
- Class II
- Quantity
- 215 units
- Official record key
device-enforcement:Z-0437-2021
Official wording
Reason: Product may be mislabeled.
Code information: Lot number Use By Date MS1913183R 5/12/2025 MS1811576R 7/22/2025 MS1913047R 6/3/2025 MS1811577R 7/22/2025 MS1913048R 6/3/2025 MS1811578R 7/22/2025 MS1913048R1 7/22/2025 MS1913049R 6/3/2025 MS1913049R 6/3/2025 MS1811579R 7/22/2025 MS1913050R 6/3/2025 MS1913050R 6/3/2025 MS1811580R 7/22/2025 MS1913051R 6/3/2025 MS1811581R 7/22/2025 MS1912629R 6/3/2025 MS1811650R 7/22/2025 MS1912633R 6/3/2025 MS1912633R 6/3/2025 MS1811651R 7/22/2025 MS1913077R 6/3/2025 MS1913077R 6/3/2025 MS1811608R 7/22/2025 MS1913078R 6/3/2025 MS1811609R 7/22/2025 MS1913079R 6/3/2025 MS1811652R 7/22/2025 MS1913080R 6/3/2025 MS1811653R 7/22/2025 MS1912634R 6/3/2025 MS1912634R 6/3/2025 MS1811654R 7/22/2025 MS1912634R1 7/22/2025 MS1913032R 6/3/2025 MS1811610R 7/22/2025 MS1913030R 6/3/2025 MS1811637R 7/22/2025 MS1913031R 6/3/2025 MS1811655R 7/22/2025 MS1912635R 5/26/2025 MS1912635R 5/26/2025 MS1912635R1 7/22/2025 MS1811656R 7/22/2025 MS1912632R 6/3/2025 MS1912632R 6/3/2025 MS1912632R1 7/22/2025 MS1811657R 7/22/2025
Distribution pattern: Product was distributed in US - CA, IL, MD, OH, and NJ
Derived failure modes
-
Labeling or packaging
mislabeled