FDA Medical Device Recalls (openFDA)
Merete Medical GmbH: OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
- Recall number
- Z-0438-2021
- Recalling firm
- Merete Medical GmbH
- Product
- OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
- Status
- Terminated
- Initiated
- 2020-09-18
- Posted
- not on file
- Terminated
- 2021-05-13
- Reason
- Product may be mislabeled.
- Root cause
- Process design
- Action
- The recalling firm contacted their importer via email to notify them of the recall. The importer contacted impacted distributors by phone to notify them of the incident and ask that product be shipped back. Customers were provided with overnight shipping labels to ship the product back to the importer. The recalling firm will reconcile returned product quantities against shipping records to ensure all product is returned.
- Quantity
- 144 units
- Distribution
- Product was distributed in US - CA, IL, MD, OH, and NJ
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K181026"]
- PMA numbers
- not on file
- Product code
- HSB
- Firm FEI
- 3002949614
- Firm city
- Berlin
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28