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Recall Observatory FDA recall evidence

Device product

RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.

Z-0828-2015

October 07, 2014

Class II

Product summary

Firm
Mako Surgical Corporation
Event
Event 69465
Status
Terminated
Classification
Class II
Quantity
Total 404
Official record key
device-enforcement:Z-0828-2015

Official wording

Reason: MAKO has identified the potential that the shell impactors may be damaged intraoperatively.

Code information: Part Number: 112710, Lot Numbers: 120027, 120041, 120052, 120074, 120076 and 120075.

Distribution pattern: Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    MAKO has identified the potential that the shell impactors may be damaged intraoperatively.