MOLLI 2 Systems
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
MOLLI OncoPen |
Various |
MP2015A |
MOLLI 2 Tablet |
Various |
MT2001 |
MOLLI 2 Wand |
Various |
MP2001 |
MOLLI Introducer And MOLLI Marker |
Various |
MS-00009 |
MOLLI Introducer And MOLLI Marker |
Various |
MM1000 |
Issue
Stryker has updated the MOLLI 2 system Instructions for Use (IFU) following two medical device reports (MDRs) submitted to the FDA (June 5 2025). These reports involved patient injuries associated with MOLLI Marker dislodgement or dislocation due to magnetic attraction from magnetized surgical tools. The updated IFU now includes an additional warning that using magnetized surgical tools in close proximity to the marker during localization may lead to marker dislodgement.
Additional information
Details
| Stryker Endoscopy, A Div. Of Stryker Corp. Dba Stryker Endoscopy |
| 5900 Optical Court, San Jose, California, United States, 95138 |
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