Zimmer CAS
Montreal, Quebec, CA
ZIMMER CAS appears in FDA device records in Montreal, Quebec, CA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Zimmer CAS carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Orthosoft, Inc. dba Zimmer CASenforcement report, recall
510(k) clearance history
FDA records hold 3 510(k) clearances for Zimmer CAS between 2011 and 2014. The busiest year on record is 2011, with 1. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K141601 | IASSIST KNEE SYSTEM | OLO | Substantially Equivalent | |
| K131129 | CAS PSI SHOULDER | KWS | Substantially Equivalent | |
| K110054 | NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE | OLO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617840 | 3003714383 | ZIMMER CAS | 75 QUEEN ST., SUITE 3300, MONTREAL, QUEBEC H3C 2N6 CA | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MOQBattery, Replacement, Rechargeable
- LHOInstrument, Quality-Assurance, Radiologic
- ONNIntraoperative Orthopedic Joint Assessment Aid
- OOGKnee Arthroplasty Implantation System
- GEYMotor, Surgical Instrument, Ac-Powered
- HAWNeurological Stereotaxic Instrument
- PBFOrthopaedic Surgical Planning And Instrument Guides
- SBFOrthopedic Augmented Reality
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- PBIProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- QHEShoulder Arthroplasty Implantation System
- PHXShoulder Prosthesis, Reverse Configuration
- LLZSystem, Image Processing, Radiological
- JACSystem, X-Ray, Film Marking, Radiographic
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0721-2022 | NavitrackER Kit A: Knee, Model Number 20-8000-000-07, | The product was released for distribution without passing sterilization results, which could potentially lead to insufficient sterility of the product. The highest severity risk is infection leading to surgical intervention. | Class II | Open, Classified | |
| Z-1868-2017 | SmartTools Knee System Orthopedic Stereotaxic Instrument | There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P | Class II | Terminated | |
| Z-1701-2015 | Tibial Alignment Guide; Orthopedic Stereotaxic Instrument; | Zimmer CAS has determined that the potential exists for the spikes on the iASSIST Tibial Alignment Guide to bend or break during insertion or extraction from the tibia during use. | Class II | Terminated | |
| Z-0495-2015 | PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components. | Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw. | Class II | Terminated | |
| Z-1881-2017 | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash. | Class II | Terminated | |
| Z-2048-2017 | NDI P7 Position Sensor, Stereotaxic Instrument | Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage. | Class II | Terminated | |
| Z-2076-2017 | Navitrack System - OS Knee Universal, Stereotaxic instrument | Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies . | Class II | Terminated | |
| Z-2075-2017 | Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument | ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3. | Class III | Terminated | |
| Z-2227-2017 | Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008 | Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain