FDAClass IINovember 18, 2020

OsteoBridge Intramedullary Diaphysis Segment Fixation recall: Labeling Error

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

Why was OsteoBridge Intramedullary Diaphysis Segment Fixation recalled?

Product may be mislabeled.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
Recalling firm
Merete Medical GmbH
Quantity
215 units
Distribution
Product was distributed in US - CA, IL, MD, OH, and NJ
Recall date
November 18, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls