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
Product summary
- 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
Potential disassociation of the orientation pin.