The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.
Recall
- Recall Number
- Z-2197-2017
- Event Number
- 77115
- Firm
- Acumed LLC
- FEI Number
- 1000125930
- Product Code
- KWI
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 20, 2017
- Terminated
- December 1, 2017
- Address
- 5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9432
Description
The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surgeons with orthopedic training. The device is to be implanted by the surgeon in a sterile operating room setting. Implants are provided in sterile packages. The Acumed Anatomic Radial Head Slide-Loc System consists of modular heads and stems with accessories for anatomical replacement of the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitellum of the distal humerus. The modular heads and stems are single use implantable devices. Each Acumed Slide-Loc Anatomic Radial Head System Set consists of 76 parts/instruments.
The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Head System based on its performance in the market. The firm received product complaints regarding instrumentation performance, trial product design, and implant dissociations.
The firm sent the Urgent Voluntary Medical Device Removal and Market Discontinuation letter to consignees on April 20, 2017. Consignees who would like to return product should contact Acumed Agent Inventory via email at [email protected] to obtain Return Material Authorization (RMA) number. Consignees should return the completed survey via email to [email protected]. Customer can call 877-627-9957, option 4, or send email to [email protected] if they have any adverse reactions or quality problem to report. Customers who have questions about this recall should contact Acumed Business Services via email at [email protected] or call 877-627-9957, option 4.
US Nationwide distribution in the states of AK, AZ, CA, CO, CT, FL, HI, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, and WA and in Puerto Rico.
13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts)