Date Initiated by Firm | September 18, 2020 |
Create Date | November 06, 2020 |
Recall Status1 |
Terminated 3 on May 13, 2021 |
Recall Number | Z-0438-2021 |
Recall Event ID |
86526 |
510(K)Number | K181026 |
Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
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Product | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) |
Code Information |
Lot Number Use By Date MS1912994R 6/4/2025 MS1811555R 7/24/2025 MS1913023R 6/4/2025 MS1811556R 7/24/2025 MS1913024R 6/4/2025 MS1913024R 6/4/2025 MS1811557R 7/24/2025 MS1913027R 6/4/2025 MS1811585R 7/23/2025 MS1913028R 6/4/2025 MS1811604R 7/23/2025 MS1913029R 6/4/2025 MS1913029R 6/4/2025 MS1811605R 7/23/2025 MS1913038R 6/4/2025 MS1811606R 7/23/2025 MS1811607R 6/4/2025 MS1811607R1 7/23/2025 MS1913039R 6/4/2025 MS1811624R 7/23/2025 MS1811673R 6/4/2025 MS1811625R 7/23/2025 MS1811673R1 7/23/2025 MS1811634R 6/4/2025 MS1811634R1 7/23/2025 MS1913041R 6/4/2025 MS1811623R 7/24/2025 MS1913042R 6/4/2025 MS1811635R 7/24/2025 MS1913043R 6/4/2025 MS1913043R 6/4/2025 MS1811636R 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 | 144 units |
Distribution | Product was distributed in US - CA, IL, MD, OH, and NJ |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = HSB
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