Device product
RESTORIS PST Acetabular Straight Shell Impactors 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-0829-2015
Product summary
- Event
- Event 69465
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total 404
- Official record key
device-enforcement:Z-0829-2015
Official wording
Reason: MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Code information: Part Number: 207390, Lot Numbers: 21948201, 21948302, 21948403, 21948501, 21948605 and 21948704.
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
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.