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U.S. Department of Health and Human Services

Class 2 Device Recall OsteoBridge

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  Class 2 Device Recall OsteoBridge see related information
Date Initiated by Firm September 18, 2020
Create Date November 06, 2020
Recall Status1 Terminated 3 on May 13, 2021
Recall Number Z-0437-2021
Recall Event ID 86526
510(K)Number K181026  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
Code Information 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 
Recalling Firm/
Manufacturer		 Merete Medical GmbH
Alt-Lankwitz 102
Berlin Germany
Manufacturer Reason
for Recall		 Product may be mislabeled.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = Merete GmbH
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