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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-0436-2021
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 (femur)
Code Information Lot Number Use By Date  MS1913083R 6/4/2025 MS1811571R 7/24/2025 MS1913083R1 7/24/2025 MS1913084R 6/4/2025 MS1811572R 7/17/2025 MS1811572R1 7/24/2025 MS1913085R 6/4/2025 MS1811573R 7/17/2025 MS1913086R 6/4/2025 MS1811660R 7/17/2025 MS1913087R 6/4/2025 MS1913087R 6/4/2025 MS1811661R 7/17/2025 MS1912446R 7/17/2025 MS1913087R1 7/17/2025 MS1913098R 6/4/2025 MS1811613R 7/17/2025 MS1913099R 6/4/2025 MS1811614R 7/17/2025 MS1913100R 6/4/2025 MS1913100R 6/4/2025 MS1811662R 7/17/2025 MS1913100R1 7/17/2025 MS1811663R 6/4/2025 MS1811663R1 7/17/2025 MS1913102R 6/4/2025 MS1913102R 6/4/2025 MS1913102R1 7/17/2025 MS1811664R 7/17/2025 MS1913114R 6/4/2025 MS1913114R 6/4/2025 MS1811618R 7/17/2025 MS1913114R1 7/17/2025 MS1913115R 6/4/2025 MS1913115R 6/4/2025 MS1811665R 7/21/2025 MS1913115R1 7/21/2025 MS1913116R 6/4/2025 MS1913116R 6/4/2025 MS1811666R 7/21/2025 MS1913117R 6/4/2025 MS1913117R 6/4/2025 MS1913117R1 7/21/2025 MS1811667R 7/21/2025 MS1913118R 6/4/2025 MS1913118R 6/4/2025 MS1811668R 7/21/2025 MS1912441R 7/21/2025 MS1811642R 6/4/2025 MS1913126R 6/4/2025 MS1811642R 6/4/2025 MS1913126R 6/4/2025 MS1913126R 6/4/2025 MS1811642R 6/4/2025 MS1811642R1 7/21/2025 MS1913127R 6/4/2025 MS1811882R 7/21/2025 MS1811643R 7/22/2025 MS1913128R 6/4/2025 MS1913128R 6/4/2025 MS1912443R 7/21/2025 MS1811644R 7/21/2025 MS1913129R 6/4/2025 MS1913129R 6/4/2025 MS1912444R 7/21/2025 MS1811645R 7/21/2025 MS1913130R 6/4/2025 MS1811619R 7/21/2025 MS1913131R 6/4/2025 MS1811646R 7/21/2025 MS1913132R 6/4/2025 MS1811620R 7/21/2025 MS1913133R 6/4/2025 MS1811647R 7/24/2025 
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 354 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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