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Zimmer CAS

Canada·CA-MF-000000791

Last updated September 17, 2026

Information

Country: Canada
Address: 75, Queen Street, Montreal, Canada
Website: labeling.zimmerbiomet.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Sankalp Dere
EUDAMED SRN: CA-MF-000000791
FDA FEI Number: 3003714383
DUNS Number: —

Catalogue (31)

Device	Model / Reference	Registries	Class	Status
Rosa Polyaxial Reference Size 3	20-8020-037-00	EUDAMED	Class IIa	Active
ROSA® Base Reference Frame	20-8020-002-00	EUDAMEDFDA UDI	Class I	Active
Rosa Stabilizer Tissue Deflector 60mm	20-8020-040-00	EUDAMED	Class IIa	Active
Iassist Knee System	K141601	FDA 510(k)	Class II	Active
Navitrack System - Os Knee Universal, Cas Same Incision Tibia Reference	K110054	FDA 510(k)	Class II	Active
Cas Psi Shoulder	K131129	FDA 510(k)	Class II	Active
Rosa® Knee Inst Case	20-8020-063-00	EUDAMEDFDA UDI	Class I	Active
Rosa Ppk Med Cut Guide A-R	20-8020-031-00	EUDAMEDFDA UDI	Class IIa	Active
ROSA® Knee	20-8020-130-01	EUDAMED	Class IIa	Active
Rosa® Knee Tray	20-8020-064-00	EUDAMEDFDA UDI	Class I	Active
Rosa®	20-8020-159-00	EUDAMEDFDA UDI	Class IIa	Active
Rosa Pin Stabilizer 60mm	20-8020-039-00	EUDAMED	Class IIa	Active
ROSA® Knee	20-8020-195-00	EUDAMEDFDA UDI	Class IIa	Active
Rosa®	20-8020-158-00	EUDAMEDFDA UDI	Class IIa	Active
Rosa Ppk Med Cut Guide B-L	20-8020-032-00	EUDAMEDFDA UDI	Class IIa	Active
ROSA® Knee	20-8020-194-00	EUDAMEDFDA UDI	Class IIa	Active
Rosa® Knee Optical Unit	20-8020-120-01	EUDAMEDFDA UDI	Class I	Active
ROSA® Knee	20-8020-193-00	EUDAMEDFDA UDI	Class IIa	Active
Rosa Ppk Med Cut Guide A-L	20-8020-030-00	EUDAMEDFDA UDI	Class IIa	Active
Rosa Pka Validation Tool	20-8020-034-00	EUDAMEDFDA UDI	Class IIa	Active
ROSA® Recon Platform	20-8020-100-26	EUDAMED	Class I	Active
Rosa Ppk Med Cut Guide B-R	20-8020-033-00	EUDAMEDFDA UDI	Class IIa	Active
ROSA® Arm Reference Frame	20-8020-015-00	EUDAMEDFDA UDI	Class I	Active
ROSA Partial Knee Software v1.2.2	20-8020-150-01	EUDAMED	Class IIa	Active
Rosa® Knee Persona® Id Plate	20-8020-060-01	EUDAMEDFDA UDI	Class I	Active
Rosa® Knee Vanguard® Id Plate	20-8020-062-01	EUDAMEDFDA UDI	Class I	Active
Rosa®	20-8020-160-00	EUDAMEDFDA UDI	Class IIa	Active
ROSA® Arm Instrument Interface	20-8020-004-00	EUDAMEDFDA UDI	Class I	Active
Rosa Polyaxial Reference Size 6	20-8020-038-00	EUDAMED	Class IIa	Active
Rosa® Knee Nexgen® Id Plate	20-8020-061-01	EUDAMEDFDA UDI	Class I	Active
ROSA® Recon	20-8020-110-26	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

Biomet Global Supply Chain Center B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 19, 2015	Z-1701-2015	—	terminated	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.
Nov 3, 2014	Z-0495-2015	—	terminated	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.