Z-0829-2015 Class II Terminated
FDA device recall Z-0829-2015 was initiated by Mako Surgical Corporation on Oct 7, 2014 and is designated Class II. Reason for recall: MAKO has identified the potential that the shell impactors may be damaged intraoperatively. The recall status is terminated (terminated Oct 3, 2016). Affected quantity: Total 404.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 24, 2014
- Initiation Date
- Oct 7, 2014
- Termination Date
- Oct 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total 404
Product Description
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.
Reason for Recall
MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
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.
Code Information
Part Number: 207390, Lot Numbers: 21948201, 21948302, 21948403, 21948501, 21948605 and 21948704.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0829-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026