RESTORIS PST Acetabular Offset Shell Impactors An recall
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the…
Why was RESTORIS PST Acetabular Offset Shell Impactors An recalled?
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 206276, Lot Numbers: 6011112, 6020114, 6030314, 6030712, 6110612 and E453704.
- Product
- RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the…
- Recalling firm
- Mako Surgical Corporation
- Quantity
- Total 404
- 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.
- Recall date
- December 24, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)