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.
Reported: December 24, 2014 Initiated: October 7, 2014 #Z-0828-2015
Product Description
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.
Reason for Recall
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Details
- Recalling Firm
- Mako Surgical Corporation
- Units Affected
- Total 404
- Distribution
- 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.
- Location
- Plantation, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mako Surgical Corporation. Units affected: Total 404.
Why was this product recalled? ▼
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2014. Severity: Moderate. Recall number: Z-0828-2015.
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