Billerica, MA, US · 19 510(k) clearances · 9 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 13 | 2023-07-17 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | 2 | 2023-09-08 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | Class II | Orthopedic | 2 | 2023-05-23 |
| OOG | Knee Arthroplasty Implantation System | Class II | Orthopedic | 1 | 2021-04-19 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 1 | 2020-09-24 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-03-25 | Class II | Ongoing | Z-1569-2025 | restor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for … | — | The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a sta… |
| 2024-03-11 | Class II | Ongoing | Z-1591-2024 | Identity Imprint PS Tibial Tray Size 4: Lot 540287 | — | Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouchi… |
| 2023-06-16 | Class II | Ongoing | Z-2405-2023 | CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO | — | 30mm screws were labeled as 25mm screws. |
| 2022-11-14 | Class II | Ongoing | Z-1133-2023 | iTotal Identity Impactor Handle, Model No. 1080-212/ED-07827 REV AE | — | Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the… |
| 2022-02-22 | Class II | Completed | Z-0899-2022 | iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101 | — | Incorrect tibial base plate implant packaged in kit |
| 2020-09-21 | Class II | Terminated | Z-0475-2021 | iTotal Hip Replacement System, Model number HAA-050-D020-020102 The Conformis Hip System includes standard hip replac… | — | Incorrect hip components were provided in kits. |
| 2020-07-20 | Class II | Terminated | Z-2849-2020 | Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL … | — | Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920 |
| 2020-02-03 | Class II | Terminated | Z-1628-2020 | iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The … | — | A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. |
| 2020-02-03 | Class II | Terminated | Z-1627-2020 | iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage:… | — | A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-09-08 | K232426 | Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts | MBH | Class II | Orthopedic |
| 2023-07-21 | K223316 | Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System | MBH | Class II | Orthopedic |
| 2023-07-17 | K230846 | iTotal Identity Knee Replacement System; Identity Imprint Knee Replacement System | JWH | Class II | Orthopedic |
| 2023-05-26 | K231233 | Identity Imprint CR KRS and Identity Imprint PS KRS | JWH | Class II | Orthopedic |
| 2023-05-23 | K231178 | ACTERA hip system | MEH | Class II | Orthopedic |
| 2023-04-27 | K230844 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert | JWH | Class II | Orthopedic |
| 2022-08-04 | K221104 | Actera hip system | MEH | Class II | Orthopedic |
| 2022-07-26 | K221404 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | JWH | Class II | Orthopedic |
| 2022-05-10 | K221059 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | JWH | Class II | Orthopedic |
| 2021-11-10 | K213389 | Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System | JWH | Class II | Orthopedic |
| 2021-09-23 | K212411 | Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) | JWH | Class II | Orthopedic |
| 2021-05-12 | K210809 | iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS) | JWH | Class II | Orthopedic |
| 2021-05-06 | K210191 | Identity Imprint Knee Replacement System | JWH | Class II | Orthopedic |
| 2021-04-19 | K203421 | Triathlon AS-1 | OOG | Class II | Orthopedic |
| 2021-02-17 | K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System | JWH | Class II | Orthopedic |
| 2020-12-22 | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement | JWH | Class II | Orthopedic |
| 2020-09-24 | K202484 | Cordera Hip System | LPH | Class II | Orthopedic |
| 2020-06-16 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System | JWH | Class II | Orthopedic |
| 2020-03-13 | K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System | JWH | Class II | Orthopedic |