OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
Medical device recall Z-0435-2021. Published in FDA’s Enforcement Report on Nov 18, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 18, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 5 states named in where it went
- 306 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is 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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Product may be mislabeled.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
306 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,999 characters
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…
FDA’s list runs to 3,151 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Product was distributed in US - CA, IL, MD, OH, and NJ
The states and territories these words name
- California
- Illinois
- Maryland
- New Jersey
- Ohio
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 18, 2020.
- FDA classified it on Nov 6, 2020.
- FDA’s Enforcement Report published it on Nov 18, 2020.
- FDA terminated it on May 13, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Merete Medical GmbH, of Berlin, Germany.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,151 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.