Device product
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
Z-0438-2021
Product summary
- Event
- Event 86526
- Status
- Terminated
- Classification
- Class II
- Quantity
- 144 units
- Official record key
device-enforcement:Z-0438-2021
Official wording
Reason: Product may be mislabeled.
Code information: Lot Number Use By Date MS1912994R 6/4/2025 MS1811555R 7/24/2025 MS1913023R 6/4/2025 MS1811556R 7/24/2025 MS1913024R 6/4/2025 MS1913024R 6/4/2025 MS1811557R 7/24/2025 MS1913027R 6/4/2025 MS1811585R 7/23/2025 MS1913028R 6/4/2025 MS1811604R 7/23/2025 MS1913029R 6/4/2025 MS1913029R 6/4/2025 MS1811605R 7/23/2025 MS1913038R 6/4/2025 MS1811606R 7/23/2025 MS1811607R 6/4/2025 MS1811607R1 7/23/2025 MS1913039R 6/4/2025 MS1811624R 7/23/2025 MS1811673R 6/4/2025 MS1811625R 7/23/2025 MS1811673R1 7/23/2025 MS1811634R 6/4/2025 MS1811634R1 7/23/2025 MS1913041R 6/4/2025 MS1811623R 7/24/2025 MS1913042R 6/4/2025 MS1811635R 7/24/2025 MS1913043R 6/4/2025 MS1913043R 6/4/2025 MS1811636R 7/24/2025
Distribution pattern: Product was distributed in US - CA, IL, MD, OH, and NJ
Derived failure modes
-
Labeling or packaging
mislabeled