Recall Z-0438-2021— Merete Medical GmbH

Name: FDA recall Z-0438-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-18

Class II · Terminated

Class II FDA medical device recall by Merete Medical GmbH, initiated 2020-09-18, terminated 2021-05-13. It names one FDA 510(k) clearance: K181026. Product: OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus). Reason: Product may be mislabeled..

Recalling firm: Merete Medical GmbH
Classification: Class II
Status: Terminated
Initiated: 2020-09-18
Terminated: 2021-05-13
Firm location: Berlin, Germany

510(k) clearances named in this recall

1 on FDA's record

K181026 — OsteoBridge IDSF SystemMerete GmbH·cleared 2018-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Product may be mislabeled.

Data sourced from openFDA. This site is unofficial and independent of the FDA.