Device recall: OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
Class II FDA enforcement event 86526. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Product may be mislabeled.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Merete Medical GmbH started this device recall on 18 Sep 2020. The firm address in the FDA record is in Berlin. FDA put the recall in Class II. FDA event 86526 has 4 product records. The first FDA enforcement report date is 18 Nov 2020. The record gives the status Terminated, with the termination date 13 May 2021.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Product was distributed in US - CA, IL, MD, OH, and NJ
Recalling firm
Merete Medical GmbH, Berlin, Germany.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0435-2021 | OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails | 306 units | Class II | Terminated | 18 Nov 2020 |
| Z-0436-2021 | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur) | 354 units | Class II | Terminated | 18 Nov 2020 |
| Z-0437-2021 | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia) | 215 units | Class II | Terminated | 18 Nov 2020 |
| Z-0438-2021 | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) | 144 units | Class II | Terminated | 18 Nov 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 4Median of the firm: 4
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 18 Jan 2022 | Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only Event 89482 | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0435-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 86526. https://recallregister.com/fda/ii/86526/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Product was distributed in US - CA, IL, MD, OH, and NJ
- What quantity of product is in FDA event 86526?
- The event has 4 product records. The first record gives this quantity:
306 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.