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

FDA Device Recall #Z-0436-2021 — Class II — September 18, 2020

Recall Summary

Recall Number Z-0436-2021
Classification Class II — Moderate risk
Date Initiated September 18, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Merete Medical GmbH
Location Berlin
Product Type Devices
Quantity 354 units

Product Description

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

Reason for Recall

Product may be mislabeled.

Distribution Pattern

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

Lot / 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

Other Recalls from Merete Medical GmbH

Recall # Classification Product Date
Z-0650-2022 Class II Merete PediatrOS RigidTack, REF CP20120, Size 2... Jan 18, 2022
Z-0437-2021 Class II OsteoBridge Intramedullary Diaphysis Segment Fi... Sep 18, 2020
Z-0438-2021 Class II OsteoBridge Intramedullary Diaphysis Segment Fi... Sep 18, 2020
Z-0435-2021 Class II OsteoBridge Intremedullary Knee Arthrodesis (IK... Sep 18, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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