Orthosoft Inc. (d/b/a) Zimmer CAS
CanadaFDA applicant, unverified
- Devices
- 27
- FDA recalls
- 71 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Orthosoft Inc. (d/b/a) Zimmer CAS makes
Orthosoft Inc. (d/b/a Zimmer CAS) manufactures robotic-assisted orthopedic systems for shoulder, hip, and knee surgeries, including the ROSA Shoulder, ROSA Hip, and ROSA Knee Systems. Their portfolio also includes the Signature ONE System for joint replacement implants and iASSIST Knee System for computer-assisted knee procedures. Additionally, they provide 3D planning software, such as Efficient Care 3D Planning, and imaging tools like OptiVu ROSA MxR for enhanced surgical guidance.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company is based in Canada and its products are listed in the FDA’s 510(k) registry. No other regulatory listings are specified.
Catalogue
Search and filter all 27 devicesFDA recalls
FDA recall records list 7 recalls initiated by Orthosoft Inc. (d/b/a) Zimmer CAS, the earliest on 2008-06-04 and the most recent on 2022-01-07. By recorded status: 1 ongoing and 6 terminated. The reasons filed fall into these groups: software or firmware, sterility or contamination, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 7 Jan 2022 Z-0721-2022 Class II Ongoing 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.
Full distribution text
- 7 Jan 2022 Z-0721-2022 Class II Ongoing 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.
2017
- 20 Feb 2017 Z-1868-2017 Class II Terminated 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
2011
- 6 Oct 2011 Z-1881-2017 Class II Terminated 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.
Full distribution text
- 6 Oct 2011 Z-1881-2017 Class II Terminated 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.
2009
- 9 Jun 2009 Z-2048-2017 Class II Terminated 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.
Full distribution text
- 9 Jun 2009 Z-2048-2017 Class II Terminated 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.
2008
- 28 Oct 2008 Z-2076-2017 Class II Terminated 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 .
Full distribution text
- 20 Jun 2008 Z-2075-2017 Class III Terminated 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.
Full distribution text
- 4 Jun 2008 Z-2227-2017 Class II Terminated 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.
- 28 Oct 2008 Z-2076-2017 Class II Terminated 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 .
Frequently asked questions
How many devices does Orthosoft Inc. (d/b/a) Zimmer CAS have in the registry?
The registry currently lists 27 devices for Orthosoft Inc. (d/b/a) Zimmer CAS. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orthosoft Inc. (d/b/a) Zimmer CAS's devices?
Among its 27 most recently registered devices, Orthosoft Inc. (d/b/a) Zimmer CAS has devices listed in FDA 510(k) (27 devices).
What risk classes do Orthosoft Inc. (d/b/a) Zimmer CAS's devices fall under?
Among its 27 most recently registered devices, the classes recorded for Orthosoft Inc. (d/b/a) Zimmer CAS's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Orthosoft Inc. (d/b/a) Zimmer CAS?
FDA recall records list 7 recalls initiated by Orthosoft Inc. (d/b/a) Zimmer CAS, the most recent initiated on 7 Jan 2022. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Orthosoft Inc. (d/b/a) Zimmer CAS in the registry?
The most recently registered devices listed for Orthosoft Inc. (d/b/a) Zimmer CAS include Signature™ ONE System, ROSA® Shoulder System, ROSA Hip System and ROSA Partial Knee System.