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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-0435-2021
Recall Event ID 86526
510(K)Number K101939  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
Code Information Lot and Use by Date  MS1709826R 5/14/2025 MS1202321R 4/21/2025 MS1506568R 5/14/2025 MS1506568R 5/14/2025 MS1202321R1 7/16/2025 MS1709826R1 7/16/2025 MS1710592R 4/21/2025 MS1506583R 5/14/2025 MS1609272R 5/14/2025 MS1710592R1 7/16/2025 MS1405272R 7/16/2025 MS1609272R1 7/16/2025 MS1506583R1 7/16/2025 MS1609591R 4/21/2025 MS1609591R1 5/14/2025 MS1609591R1 5/14/2025 MS1709825R 7/16/2025 MS1609591R2 7/16/2025 MS1710265R 4/21/2025 MS1609590R 4/21/2025 MS1711008R1 5/14/2025 MS1609083R 7/16/2025 MS1711008R2 7/16/2025 MS1710265R1 7/16/2025 MS2014265 4/17/2025 MS2014265 4/17/2025 MS1710921R 4/27/2025 MS2014265 4/17/2025 MS1710921R1 7/16/2025 MS1912442R1 7/16/2025 MS1405010R 4/27/2025 MS1506989R 5/14/2025 MS1506989R 5/14/2025 MS1709827R 7/16/2025 MS1710266R 7/16/2025 MS1506989R 5/14/2025 MS1709827R 7/16/2025 MS1710266R 7/16/2025 MS1506989R 5/14/2025 MS1709827R 7/16/2025 MS1710266R 7/16/2025 MS1710746R 4/27/2025 MS1710525R 4/27/2025 MS1304331R 5/14/2025 MS1710525R1 7/16/2025 MS1609273R 7/16/2025 MS1812116R 4/27/2025 MS1609274R 4/27/2025 MS2014170 4/17/2025 MS2014170R 7/16/2025 MS1812116R1 7/16/2025 MS1202322R 4/28/2025 MS1609683R 5/14/2025 MS1609683R 5/14/2025 MS1609683R1 7/16/2025 MS1710744R 4/28/2025 MS1202323R 4/28/2025 MS1507012R 5/14/2025 MS1608472R 5/14/2025 MS1710744R1 7/16/2025 MS1202323R1 7/16/2025 MS1710745R 4/28/2025 MS1507606R 1/8/2025 MS1303859R1 5/14/2025 MS1304612R1 5/14/2025 MS1202641R1 5/14/2025 MS1710745R1 7/16/2025 MS1303859R2 7/16/2025 MS1202363R 4/28/2025 MS1710163R 4/28/2025 MS1506572R 5/14/2025 MS1506572R 5/14/2025 MS1710163R1 7/16/2025 MS1710666R 7/16/2025 MS1710665R 4/28/2025 MS1506584R 5/14/2025 MS1710665R1 5/14/2025 MS1710665R2 7/16/2025 MS1202364R 7/16/2025 MS1303916R 7/16/2025 MS1405901R 4/28/2025 MS1710693R 4/28/2025 MS1710693R1 5/14/2025 MS1710693R2 7/16/2025 MS1710164R 7/16/2025 MS1304195R 7/16/2025 MS1710693R2 7/16/2025 MS1710164R 7/16/2025 MS1304195R 7/16/2025 MS1710693R2 7/16/2025 MS1304195R 7/16/2025 MS1506546R1 5/14/2025 MS1608831R1 6/2/2025 MS1506546R1 5/14/2025 MS1506546R1 5/14/2025 MS1608831R1 6/2/2025 MS1202527R 7/20/2025 N020711R 4/29/2025 MS1608832R 4/29/2025 MS1405856R 6/2/2025 MS1608149R 6/2/2025 MS1608832R1 7/20/2025 MS1405856R1 7/20/2025 MS1406097R1 6/2/2025 MS1507541R 5/14/2025 MS1609333R 5/14/2025 MS1609333R 5/14/2025 MS1000716R 7/20/2025 MS1608462R 4/29/2025 MS1609058R 5/14/2025 MS1000717R 5/14/2025 MS1000717R 5/14/2025 MS1609058R1 7/21/2025 MS1202314R 4/29/2025 MS1709840R 4/29/2025 MS1406083R 5/14/2025 MS1608742R 6/2/2025 MS1406083R 5/14/2025 MS1405477R1 5/14/2025 MS1608833R 6/2/2025 MS1608833R 6/2/2025 MS1609057R 4/29/2025 MS1609057R1 5/13/2025 MS1608668R 6/2/2025 MS1000719R 5/13/2025 MS1000719R 5/13/2025 MS1711010R 6/2/2025 MS1711010R 6/2/2025 MS1711010R 6/2/2025 MS1506547R 5/13/2025 MS1609059R1 6/2/2025 MS1102136R1 6/2/2025 MS1609059R1 6/2/2025 MS1406153R 6/2/2025 MS1000651R 6/2/2025 MS1405338R 6/2/2025 MS1608322R 6/2/2025 MS1507841R 5/13/2025 MS1506545R 4/29/2025 MS1303917R 5/13/2025 MS1506545R1 5/13/2025 MS1506545R1 5/13/2025 MS1202346R1 7/21/2025 MS1203156R 7/21/2025 MS1303917R1 7/21/2025 MS1710740R 4/29/2025 MS1609334R1 5/13/2025 MS1609334R2 7/21/2025  
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 306 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 MEDICAL GMBH
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