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.
Reported: May 4, 2016 Initiated: February 23, 2016 #Z-1583-2016
Product Description
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.
Reason for Recall
Potential disassociation of the orientation pin.
Details
- Recalling Firm
- Mako Surgical Corporation
- Units Affected
- 96
- Distribution
- 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.
- Location
- Plantation, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mako Surgical Corporation. Units affected: 96.
Why was this product recalled? ▼
Potential disassociation of the orientation pin.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2016. Severity: Moderate. Recall number: Z-1583-2016.
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