Reported Mar 13, 2019 · Terminated
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut…
Stryker Sustainability Solutions
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: Stryker Sustainability Solutions · 1810 W Drake Dr · Tempe, AZ · 85283-4327
Is this the product you have?
- Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
- Lot codes and dates
- Catalog Numbers375-450-000 375-940-000, 375-532-000 375-940-012, 375-534-000 375-941-000, 375-542-000 375-941-012, 375-544-000 375-941-500, 375-545-000 375-950-000, 375-548-000 375-950-012, 375-552-000 375-950-112, 375-554-000 375-951-000, 375-555-000 375-951-012, 375-562-000 375-951-100, 375-564-000 375-951-112, 375-565-000 375-951-200 and 375-747-000 375-952-000
- Lots from affected catalog numbers
273 of 273 codes
460143576875517954336806995581439518213505829094048665977692818795763880787768143979821623382969205275122769514979624438078965814410582205638297887581040176966537964118807907681447708220748829797061656807702505796496680823768146583822362982980356552450772594279650898082638814833782239108298128656317777436247969196808274681504928224388829862566343817755555797808980957708150617822462183051816694100776650679789318096123
- Amount recalled
- 14,265 units
Where it was sold
Why it was recalled
Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used.
This product could cause temporary or reversible health problems — stop using it.
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