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Recall Observatory FDA recall evidence

Device product

OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)

Z-0436-2021

September 18, 2020

Class II

Product summary

Firm
Merete Medical GmbH
Event
Event 86526
Status
Terminated
Classification
Class II
Quantity
354 units
Official record key
device-enforcement:Z-0436-2021

Official wording

Reason: Product may be mislabeled.

Code information: Lot Number Use By Date MS1913083R 6/4/2025 MS1811571R 7/24/2025 MS1913083R1 7/24/2025 MS1913084R 6/4/2025 MS1811572R 7/17/2025 MS1811572R1 7/24/2025 MS1913085R 6/4/2025 MS1811573R 7/17/2025 MS1913086R 6/4/2025 MS1811660R 7/17/2025 MS1913087R 6/4/2025 MS1913087R 6/4/2025 MS1811661R 7/17/2025 MS1912446R 7/17/2025 MS1913087R1 7/17/2025 MS1913098R 6/4/2025 MS1811613R 7/17/2025 MS1913099R 6/4/2025 MS1811614R 7/17/2025 MS1913100R 6/4/2025 MS1913100R 6/4/2025 MS1811662R 7/17/2025 MS1913100R1 7/17/2025 MS1811663R 6/4/2025 MS1811663R1 7/17/2025 MS1913102R 6/4/2025 MS1913102R 6/4/2025 MS1913102R1 7/17/2025 MS1811664R 7/17/2025 MS1913114R 6/4/2025 MS1913114R 6/4/2025 MS1811618R 7/17/2025 MS1913114R1 7/17/2025 MS1913115R 6/4/2025 MS1913115R 6/4/2025 MS1811665R 7/21/2025 MS1913115R1 7/21/2025 MS1913116R 6/4/2025 MS1913116R 6/4/2025 MS1811666R 7/21/2025 MS1913117R 6/4/2025 MS1913117R 6/4/2025 MS1913117R1 7/21/2025 MS1811667R 7/21/2025 MS1913118R 6/4/2025 MS1913118R 6/4/2025 MS1811668R 7/21/2025 MS1912441R 7/21/2025 MS1811642R 6/4/2025 MS1913126R 6/4/2025 MS1811642R 6/4/2025 MS1913126R 6/4/2025 MS1913126R 6/4/2025 MS1811642R 6/4/2025 MS1811642R1 7/21/2025 MS1913127R 6/4/2025 MS1811882R 7/21/2025 MS1811643R 7/22/2025 MS1913128R 6/4/2025 MS1913128R 6/4/2025 MS1912443R 7/21/2025 MS1811644R 7/21/2025 MS1913129R 6/4/2025 MS1913129R 6/4/2025 MS1912444R 7/21/2025 MS1811645R 7/21/2025 MS1913130R 6/4/2025 MS1811619R 7/21/2025 MS1913131R 6/4/2025 MS1811646R 7/21/2025 MS1913132R 6/4/2025 MS1811620R 7/21/2025 MS1913133R 6/4/2025 MS1811647R 7/24/2025

Distribution pattern: Product was distributed in US - CA, IL, MD, OH, and NJ

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled