Z-0436-2021Class II

OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)

Name: Z-0436-2021 OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
Creator: Merete Medical GmbH
Published: 2020-09-18
License: https://open.fda.gov/license/

Merete GmbH / initiated 2020-09-18 / Terminated / root cause: manufacturing process

FDA source

Merete Medical GmbH began a recall of OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur) on 2020-09-18. FDA classified it as Class II and gives the reason as "Product may be mislabeled". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0436-2021
Classification: Class II
Status: Terminated
Initiated: 2020-09-18
Posted: 2020-11-06
Terminated: 2021-05-13
Recalling firm: Merete GmbH
Product: OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Product may be mislabeled.
Root cause tag: manufacturing process
FDA 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 in commerce: 354 units
Distribution: Product was distributed in US - CA, IL, MD, OH, and NJ
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0436-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0435-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-18	2020-11-06
Z-0436-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-18	2020-11-06
Z-0437-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-18	2020-11-06
Z-0438-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-18	2020-11-06

Product code HSB

K181026Class IIOsteoBridge™ IDSF SystemMerete GmbH / cleared 2018-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)