CLASS II Device recall · Reported 18 Nov 2020 · FDA Enforcement Report
OsteoBridge Intramedullary Diaphysis Segment Fixation recalled
Merete Medical is recalling OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus), distributed in California, Illinois, Maryland, New Jersey, Ohio. The recall was initiated on 18 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0438-2021
- FDA event ID
- 86526
- Recalling firm
- Merete Medical, Berlin
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Sep 2020
- FDA classified
- 6 Nov 2020
- Reported
- 18 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 18 Sep 2020 | Recall initiated by company | |
| 6 Nov 2020 | Classified by FDA | +49 days |
| 18 Nov 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may be mislabeled.
Product as listed by the FDA
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
Where it was distributed
Product was distributed in US - CA, IL, MD, OH, and NJ
Questions about this recall
Is OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) recalled?
Yes. Merete Medical recalled OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) on 18 Sep 2020. The recall is Class II and its status is Terminated. Recall number Z-0438-2021.
Why was it recalled?
Product may be mislabeled.
Which lots are affected?
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
Where was it sold?
Product was distributed in US - CA, IL, MD, OH, and NJ
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Merete Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Merete PediatrOS RigidTack recalled by Merete Medical | Merete Medical | Sterility | IL |
| Device | CLASS II | OsteoBridge Intramedullary Diaphysis Segment Fixation recalled | Merete Medical | Labeling Errors | 5 states |
| Device | CLASS II | OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails recalled | Merete Medical | Labeling Errors | 5 states |
| Device | CLASS II | OsteoBridge Intramedullary Diaphysis Segment Fixation recalled | Merete Medical | Labeling Errors | 5 states |
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