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.
This recall has been terminated (originally issued December 18, 2014).
- Company
- Mako Surgical Corporation
- Recall Initiated
- October 7, 2014
- Posted
- December 18, 2014
- Terminated
- October 3, 2016
- Recall Number
- Z-0830-2015
- Quantity
- Total 404
- Firm Location
- Plantation, FL
- Official Source
- View on FDA website ↗
Reason for Recall
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
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.
Lot / Code Info
Part Number: 206276, Lot Numbers: 6011112, 6020114, 6030314, 6030712, 6110612 and E453704.
Root Cause
Device Design
Action Taken
MAKO Surgical Corporation sent an Important Medical Device Recall Notice dated October 7, 2014, to all affected customers. The letter identified the product, the problem, and hte action to be taken by the customer. Customers were instructed to review their inventory for the affected product and return affected inventory to MAKO, Ft. Lauderdale. Customers were instructed to provide the Recall Notification to all field personnel to enhance awareness of the event. Customers were instructed to complete the attached acknowledgement form indicating receipt of the notice. Customers were asked to sign and return the form to MAKO Surgical by the following methods: Email: SYKMakoFLQualitySystems@stryker.com Fax to (954) 423-1547 Mail using enclosed self addressed stamped envelope tp: MAKO Surgical Corporation 2555 Davie Road Ft. Lauderdale, FL 33317 so that the field personnel 1) Recall Notification communicated by MAKO Customer Service on 10/7/2014 to affected MAKO field personnel, directing them to review their affected customer's site inventory and return affected inventory to MAKO Ft. Lauderdale. Field personnel will sign an Acknowledgment form and return it to MAKO Quality. 2) Recall Notification communicated by MAKO Quality department to the affected sites OR Administrators notifying them of the recall event and providing an Acknowledgment form for return to MAKO Quality to document their awareness. 3) The Recall Notification provided to all MAKO field personnel to enhance awareness of the event so that the field personnel can provide answers to questions their site personnel may have regarding the event. If you have any questions contact us at (954) 628-1721.