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OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails

FDA Device Recall #Z-0435-2021 — Class II — September 18, 2020

Recall Summary

Recall Number Z-0435-2021
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 306 units

Product Description

OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails

Reason for Recall

Product may be mislabeled.

Distribution Pattern

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

Lot / Code Information

Lot and Use by Date MS1709826R 5/14/2025 MS1202321R 4/21/2025 MS1506568R 5/14/2025 MS1506568R 5/14/2025 MS1202321R1 7/16/2025 MS1709826R1 7/16/2025 MS1710592R 4/21/2025 MS1506583R 5/14/2025 MS1609272R 5/14/2025 MS1710592R1 7/16/2025 MS1405272R 7/16/2025 MS1609272R1 7/16/2025 MS1506583R1 7/16/2025 MS1609591R 4/21/2025 MS1609591R1 5/14/2025 MS1609591R1 5/14/2025 MS1709825R 7/16/2025 MS1609591R2 7/16/2025 MS1710265R 4/21/2025 MS1609590R 4/21/2025 MS1711008R1 5/14/2025 MS1609083R 7/16/2025 MS1711008R2 7/16/2025 MS1710265R1 7/16/2025 MS2014265 4/17/2025 MS2014265 4/17/2025 MS1710921R 4/27/2025 MS2014265 4/17/2025 MS1710921R1 7/16/2025 MS1912442R1 7/16/2025 MS1405010R 4/27/2025 MS1506989R 5/14/2025 MS1506989R 5/14/2025 MS1709827R 7/16/2025 MS1710266R 7/16/2025 MS1506989R 5/14/2025 MS1709827R 7/16/2025 MS1710266R 7/16/2025 MS1506989R 5/14/2025 MS1709827R 7/16/2025 MS1710266R 7/16/2025 MS1710746R 4/27/2025 MS1710525R 4/27/2025 MS1304331R 5/14/2025 MS1710525R1 7/16/2025 MS1609273R 7/16/2025 MS1812116R 4/27/2025 MS1609274R 4/27/2025 MS2014170 4/17/2025 MS2014170R 7/16/2025 MS1812116R1 7/16/2025 MS1202322R 4/28/2025 MS1609683R 5/14/2025 MS1609683R 5/14/2025 MS1609683R1 7/16/2025 MS1710744R 4/28/2025 MS1202323R 4/28/2025 MS1507012R 5/14/2025 MS1608472R 5/14/2025 MS1710744R1 7/16/2025 MS1202323R1 7/16/2025 MS1710745R 4/28/2025 MS1507606R 1/8/2025 MS1303859R1 5/14/2025 MS1304612R1 5/14/2025 MS1202641R1 5/14/2025 MS1710745R1 7/16/2025 MS1303859R2 7/16/2025 MS1202363R 4/28/2025 MS1710163R 4/28/2025 MS1506572R 5/14/2025 MS1506572R 5/14/2025 MS1710163R1 7/16/2025 MS1710666R 7/16/2025 MS1710665R 4/28/2025 MS1506584R 5/14/2025 MS1710665R1 5/14/2025 MS1710665R2 7/16/2025 MS1202364R 7/16/2025 MS1303916R 7/16/2025 MS1405901R 4/28/2025 MS1710693R 4/28/2025 MS1710693R1 5/14/2025 MS1710693R2 7/16/2025 MS1710164R 7/16/2025 MS1304195R 7/16/2025 MS1710693R2 7/16/2025 MS1710164R 7/16/2025 MS1304195R 7/16/2025 MS1710693R2 7/16/2025 MS1304195R 7/16/2025 MS1506546R1 5/14/2025 MS1608831R1 6/2/2025 MS1506546R1 5/14/2025 MS1506546R1 5/14/2025 MS1608831R1 6/2/2025 MS1202527R 7/20/2025 N020711R 4/29/2025 MS1608832R 4/29/2025 MS1405856R 6/2/2025 MS1608149R 6/2/2025 MS1608832R1 7/20/2025 MS1405856R1 7/20/2025 MS1406097R1 6/2/2025 MS1507541R 5/14/2025 MS1609333R 5/14/2025 MS1609333R 5/14/2025 MS1000716R 7/20/2025 MS1608462R 4/29/2025 MS1609058R 5/14/2025 MS1000717R 5/14/2025 MS1000717R 5/14/2025 MS1609058R1 7/21/2025 MS1202314R 4/29/2025 MS1709840R 4/29/2025 MS1406083R 5/14/2025 MS1608742R 6/2/2025 MS1406083R 5/14/2025 MS1405477R1 5/14/2025 MS1608833R 6/2/2025 MS1608833R 6/2/2025 MS1609057R 4/29/2025 MS1609057R1 5/13/2025 MS1608668R 6/2/2025 MS1000719R 5/13/2025 MS1000719R 5/13/2025 MS1711010R 6/2/2025 MS1711010R 6/2/2025 MS1711010R 6/2/2025 MS1506547R 5/13/2025 MS1609059R1 6/2/2025 MS1102136R1 6/2/2025 MS1609059R1 6/2/2025 MS1406153R 6/2/2025 MS1000651R 6/2/2025 MS1405338R 6/2/2025 MS1608322R 6/2/2025 MS1507841R 5/13/2025 MS1506545R 4/29/2025 MS1303917R 5/13/2025 MS1506545R1 5/13/2025 MS1506545R1 5/13/2025 MS1202346R1 7/21/2025 MS1203156R 7/21/2025 MS1303917R1 7/21/2025 MS1710740R 4/29/2025 MS1609334R1 5/13/2025 MS1609334R2 7/21/2025

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-0436-2021 Class II OsteoBridge Intramedullary Diaphysis Segment Fi... 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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