Recall Z-2197-2017 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Acumed LLC
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 rad
| Date | Apr 20, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 Agentinventory@acumed.net to obtain Return Material Authorization (RMA) number. Consignees should return the completed survey via email to Returns@acumed.net. Customer can call 877-627-9957, option 4, or send email to customercomplaints@acumed.net if they have any adverse reactions or quality problem to report. Customers who have questions about this recall should |
| Quantity | 13076 parts total (8373 units of parts/instruments and 4703 units of implantable parts) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131845 | ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC Acumed, LLC, Sep 30, 2013 |