FDA Device recall Z-0438-2021
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
- FDA Device
- Class II
- terminated
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class II recall of OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) by Merete Medical, citing product may be mislabeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0438-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-18 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Merete Medical |
| Distribution | CA, IL, MD, NJ, OH |
Product
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
Reason
Product may be mislabeled.
Identifiers
| code_info | Lot Number Use By Date MS1912994R 6/4/2025 MS1811555R 7/24/2025 MS1913023R 6/4/2025 MS1811556R 7/24/2025 MS19…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0438-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.