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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:199205

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

Official recall number

Z-1385-2023

Evidence summary

Product code
HSX
Recall status
Open, Classified
Event initiated
March 10, 2023
Root cause
Process change control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1385-2023

Field note

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