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Terminated

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

FDA Recall Z-0438-2021 · Posted None

Recalling FirmMerete Medical GmbH
Recall StatusTerminated
Product CodeHSB
Date Initiated2020-09-18
Date Terminated2021-05-13
Product Quantity144 units

Reason for Recall

Product may be mislabeled.

Firm 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.

Root Cause

Process design

Distribution Pattern

Product was distributed in US - CA, IL, MD, OH, and NJ

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181026OsteoBridge™ IDSF SystemMerete GmbH · 2018-10-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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