Berlin, Germany
Merete Medical GmbH recalls
2 recalls recorded since 2018, most recently on 18 January 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 January 2022
- Terminated
- 16 February 2023
- Reason
- Incorrect marketing label (25 mm) was applied to product size 20 mm.
- Distribution
- Domestic: Illinois; Foreign: Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0650-2022
- Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
Terminated Class II Medical devices
- Recall started
- 18 September 2020
- Terminated
- 13 May 2021
- Reason
- Product may be mislabeled.
- Distribution
- Product was distributed in US - CA, IL, MD, OH, and NJ
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0437-2021, Z-0438-2021, Z-0435-2021, Z-0436-2021
- OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
- OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
- OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
- OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.