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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:170821

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.

Official recall number

Z-0973-2019

Evidence summary

Product code
HRX
Recall status
Terminated
Event initiated
July 27, 2018
Root cause
Software Design Change
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0973-2019

Field note

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