Recall Z-1195-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Arthrex, Inc.
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncem
| Date | Dec 17, 2015 |
| Status | Terminated |
| Reason | Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface. |
| Root cause | Nonconforming Material/Component |
| Action | On February 5, 2016 Arthrex sent Urgent Medical Device Voluntary Recall letters to their distributors and Surgeons/Medical Facilities reporting the removal. The letter identified the reason for the recall, the potential patient impact, and actions to be taken. Users were to discontinue use of the identified affected devices and follow the instructions provided to return the affected devices that have not been implanted. To return the devices, contact Arthrex at 1-866-267-9138 or by fax at 1-239-591-6943 or via e-mail at Complaints@Arthrex.com. Customers must complete and return the Acknowl |
| Quantity | 2,378 units. |
| Distribution | Nationwide Distribution -- AR, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, WA, WI and District of Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081127 | ACCIN TOTAL KNEE SYSTEM Accelerated Innovation, LLC, Oct 17, 2008 |