Z-0438-2021Class II

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

Name: Z-0438-2021 OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)
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 (humerus) 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-0438-2021
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 (humerus)
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: 144 units
Distribution: Product was distributed in US - CA, IL, MD, OH, and NJ
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0438-2021
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)