FDA Medical Device Recalls (openFDA)
Merete Medical GmbH: OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
- Recall number
- Z-0436-2021
- Recalling firm
- Merete Medical GmbH
- Product
- OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
- 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
- 354 units
- Distribution
- Product was distributed in US - CA, IL, MD, OH, and NJ
- Lot, serial or model codes
- Lot Number Use By Date MS1913083R 6/4/2025 MS1811571R 7/24/2025 MS1913083R1 7/24/2025 MS1913084R 6/4/2025 MS1811572R 7/17/2025 MS1811572R1 7/24/2025 MS1913085R 6/4/2025 MS1811573R 7/17/2025 MS1913086R 6/4/2025 MS1811660R 7/17/2025 MS1913087R 6/4/2025 MS1913087R 6/4/2025 MS1811661R 7/17/2025 MS1912446R 7/17/2025 MS1913087R1 7/17/2025 MS1913098R 6/4/2025 MS1811613R 7/17/2025 MS1913099R 6/4/2025 MS1811614R 7/17/2025 MS1913100R 6/4/2025 MS1913100R 6/4/2025 MS1811662R 7/17/2025 MS1913100R1 7/17/2025 MS1811663R 6/4/2025 MS1811663R1 7/17/2025 MS1913102R 6/4/2025 MS1913102R 6/4/2025 MS1913102R1 7/17/2025 MS1811664R 7/17/2025 MS1913114R 6/4/2025 MS1913114R 6/4/2025 MS1811618R 7/17/2025 MS1913114R1 7/17/2025 MS1913115R 6/4/2025 MS1913115R 6/4/2025 MS1811665R 7/21/2025 MS1913115R1 7/21/2025 MS1913116R 6/4/2025 MS1913116R 6/4/2025 MS1811666R 7/21/2025 MS1913117R 6/4/2025 MS1913117R 6/4/2025 MS1913117R1 7/21/2025 MS1811667R 7/21/2025 MS1913118R 6/4/2025 MS1913118R 6/4/2025 MS1811668R 7/21/2025 MS1912441R 7/21/2025 MS1811642R 6/4/2025 MS1913126R 6/4/2025 MS1811642R 6/4/2025 MS1913126R 6/4/2025 MS1913126R 6/4/2025 MS1811642R 6/4/2025 MS1811642R1 7/21/2025 MS1913127R 6/4/2025 MS1811882R 7/21/2025 MS1811643R 7/22/2025 MS1913128R 6/4/2025 MS1913128R 6/4/2025 MS1912443R 7/21/2025 MS1811644R 7/21/2025 MS1913129R 6/4/2025 MS1913129R 6/4/2025 MS1912444R 7/21/2025 MS1811645R 7/21/2025 MS1913130R 6/4/2025 MS1811619R 7/21/2025 MS1913131R 6/4/2025 MS1811646R 7/21/2025 MS1913132R 6/4/2025 MS1811620R 7/21/2025 MS1913133R 6/4/2025 MS1811647R 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