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Recall Observatory FDA recall evidence

Device product

RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

Z-1583-2016

February 23, 2016

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 73512
Status
Terminated
Classification
Class II
Quantity
96
Official record key
device-enforcement:Z-1583-2016

Official wording

Reason: Potential disassociation of the orientation pin.

Code information: Lot #'s 28548, 29130, 29479, 30440, 31801, 31802, and 32145.

Distribution pattern: Nationwide Distribution -- AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential disassociation of the orientation pin.

Field note

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