Reported Oct 16, 2024 · Ongoing
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
- Lot codes and dates
- GTIN00848486030193
- Serial Numbers
1,422 of 1,422 codes
420007542001344200177420017942001914200234420023542002514200339420035142003594200387420042742004614200510420051542005314200602420060842006114200639420064142006484200650420065342006714200697420070942007124200729420073442007574200850420085642008684200873420089842009024200966420103442097474209750420978142097894209803420982142098644209866420987842098824209899420990042099504209955420996742100044210033421003942100514210086
- Amount recalled
- 897 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
This product could cause temporary or reversible health problems — stop using it.
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