Recall Z-1516-2017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Medtronic Sofamor Danek USA Inc
Poly Component Trial, PS, packaged in the following sizes and configurations: a) Poly Component Trial - PS 3x10, REF 90-SRK-180310 b) Poly Component Trial - PS 3x12, REF 90-SRK-180312 c) Poly Component Trial - PS 3x14, REF 90-SRK-180314 d) Poly Component Trial - PS 4x10, REF 90-SRK-180410 e) Poly Component Trial - PS 4x12, REF 90-SRK-180412 f) Poly Component Trial - PS 4x14, REF 90-SRK-180414 g)
| Date | Feb 20, 2017 |
| Status | Terminated |
| Reason | The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. |
| Root cause | Under Investigation by firm |
| Action | Medtronic initiated their recall on 20 February 2017, by letter delivered by Fed Ex . The letter was addressed to the Risk/Materials Manager and stated that a Medtronic Clinical Specialist would coordinate the removal of the Responsive Orthopedics Total Knee Arthroplasty (TKA) System instrument sets from the premises. Customers with questions were instructed to contact the Medtronic Post-Market Quality Team at 901-399-3197. |
| Quantity | 111 units |
| Distribution | US distribution to AR, MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150496 | Total Knee Arthroplasty System Responsive Orthopedics, LLC, Jun 12, 2015 |