FDA Enforcement
Class II
Terminated
RESTORIS PST Acetabular Offset 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.
Recall: Z-0830-2015
·
Reported December 24, 2014
Enforcement
- Recall Number
- Z-0830-2015
- Event ID
- 69465
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Mako Surgical Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 24, 2014
- Initiation Date
- October 7, 2014
- Classification Date
- December 18, 2014
- Termination Date
- October 3, 2016
- Address
- 2555 Davie Rd Ste 110, N/A, Plantation, FL, 33317-7424, United States
Description
RESTORIS PST Acetabular Offset 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.
Reason
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
Code Info
Part Number: 206276, Lot Numbers: 6011112, 6020114, 6030314, 6030712, 6110612 and E453704.
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.
Quantity
Total 404