Z-0437-2021Class II

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

Name: Z-0437-2021 OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
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 (tibia) 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-0437-2021
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 (tibia)
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: 215 units
Distribution: Product was distributed in US - CA, IL, MD, OH, and NJ
Product codes and lots: Lot number Use By Date MS1913183R 5/12/2025 MS1811576R 7/22/2025 MS1913047R 6/3/2025 MS1811577R 7/22/2025 MS1913048R 6/3/2025 MS1811578R 7/22/2025 MS1913048R1 7/22/2025 MS1913049R 6/3/2025 MS1913049R 6/3/2025 MS1811579R 7/22/2025 MS1913050R 6/3/2025 MS1913050R 6/3/2025 MS1811580R 7/22/2025 MS1913051R 6/3/2025 MS1811581R 7/22/2025 MS1912629R 6/3/2025 MS1811650R 7/22/2025 MS1912633R 6/3/2025 MS1912633R 6/3/2025 MS1811651R 7/22/2025 MS1913077R 6/3/2025 MS1913077R 6/3/2025 MS1811608R 7/22/2025 MS1913078R 6/3/2025 MS1811609R 7/22/2025 MS1913079R 6/3/2025 MS1811652R 7/22/2025 MS1913080R 6/3/2025 MS1811653R 7/22/2025 MS1912634R 6/3/2025 MS1912634R 6/3/2025 MS1811654R 7/22/2025 MS1912634R1 7/22/2025 MS1913032R 6/3/2025 MS1811610R 7/22/2025 MS1913030R 6/3/2025 MS1811637R 7/22/2025 MS1913031R 6/3/2025 MS1811655R 7/22/2025 MS1912635R 5/26/2025 MS1912635R 5/26/2025 MS1912635R1 7/22/2025 MS1811656R 7/22/2025 MS1912632R 6/3/2025 MS1912632R 6/3/2025 MS1912632R1 7/22/2025 MS1811657R 7/22/2025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0437-2021
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)