CLASS II Device recall · Reported 18 Nov 2020 · FDA Enforcement Report
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails recalled
Merete Medical is recalling OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails, distributed in California, Illinois, Maryland, New Jersey, Ohio. The recall was initiated on 18 Sep 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0435-2021
- FDA event ID
- 86526
- Recalling firm
- Merete Medical, Berlin
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Sep 2020
- FDA classified
- 6 Nov 2020
- Reported
- 18 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 18 Sep 2020 | Recall initiated by company | |
| 6 Nov 2020 | Classified by FDA | +49 days |
| 18 Nov 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may be mislabeled.
Product as listed by the FDA
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
Where it was distributed
Product was distributed in US - CA, IL, MD, OH, and NJ
Questions about this recall
Why was it recalled?
Product may be mislabeled.
Which lots are affected?
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
Where was it sold?
Product was distributed in US - CA, IL, MD, OH, and NJ
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 86526This product is part of a recall event; the main page for the event is OsteoBridge Intramedullary Diaphysis Segment Fixation recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | OsteoBridge Intramedullary Diaphysis Segment Fixation recalled | Merete Medical | Labeling Errors | 5 states | |
| CLASS II | OsteoBridge Intramedullary Diaphysis Segment Fixation recalled | Merete Medical | Labeling Errors | 5 states | |
| CLASS II | OsteoBridge Intramedullary Diaphysis Segment Fixation recalled | Merete Medical | Labeling Errors | 5 states |
More recalls from Merete Medical
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Merete PediatrOS RigidTack recalled by Merete Medical | Merete Medical | Other | IL |
| Device | CLASS II | OsteoBridge Intramedullary Diaphysis Segment Fixation recalled | Merete Medical | Labeling Errors | 5 states |
| Device | CLASS II | OsteoBridge Intramedullary Diaphysis Segment Fixation recalled | Merete Medical | Labeling Errors | 5 states |
| Device | CLASS II | OsteoBridge Intramedullary Diaphysis Segment Fixation recalled | Merete Medical | Labeling Errors | 5 states |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |