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Zimmer Trabecular Metal Technology, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 10 POMEROY RD., Parsippany, NJ, 07054
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3005751028
DUNS Number: —

Catalogue (895)

Page 5 of 18

Device	Model / Reference	Registries	Class	Status
Mergence™-S	96-108-10071	FDA UDI	Class I	Active
Bigliani/Flatow® Trabecular Metal™	00-4326-046-52	FDA UDI	Class II	Active
TM Ardis® Trabecular Metal™	06-701-06111	FDA UDI	Class II	Active
Vista®-S	06-402-02051	FDA UDI	Class II	Active
Trabecular Metal™	00-5451-052-01	FDA UDI	Class I	Active
Trabecular Metal™	00-5452-013-52	FDA UDI	Class II	Active
Trabecular Metal™	00-4894-066-10	FDA UDI	Class II	Active
Trabecular Metal™	00-4894-062-10	FDA UDI	Class II	Active
Trabecular Metal™	00-7000-072-70	FDA UDI	Class II	Active
Nexgen®	00-5879-067-29	FDA UDI	Class I	Active
Mergence™-S	96-108-27111	FDA UDI	Class I	Active
Trabecular Metal™	00-5451-018-31	FDA UDI	Class II	Active
TM Ardis® Trabecular Metal™	06-701-02141	FDA UDI	Class II	Active
Mergence™-S	96-101-02081	FDA UDI	Class II	Active
Nexgen® Trabecular Metal™	00-5446-054-36	FDA UDI	Class II	Active
Mergence™-S	96-108-02001	FDA UDI	Class I	Active
Nexgen® Trabecular Metal™	00-5445-056-36	FDA UDI	Class II	Active
Mergence™-S	96-108-40091	FDA UDI	Class II	Active
Mergence™-S	96-108-20081	FDA UDI	Class I	Active
Trabecular Metal™	00-1197-070-10	FDA UDI	Class II	Active
TM Ardis® Trabecular Metal™	06-701-06091	FDA UDI	Class II	Active
Trabecular Metal™	06-115-00181	FDA UDI	Class II	Active
Trabecular Metal™	00-5452-018-31	FDA UDI	Class II	Active
Trabecular Metal™	06-165-01141	FDA UDI	Class II	Active
Nexgen®	00-5887-047-00	FDA UDI	Class I	Active
Explant™	00-7052-044-00	FDA UDI	Class I	Active
Trabecular Metal™	00-7000-048-20	FDA UDI	Class II	Active
TM Ardis® Trabecular Metal™	06-701-05131	FDA UDI	Class II	Active
Vista®-S	06-401-06051	FDA UDI	Class II	Active
Trabecular Metal™	06-115-00361	FDA UDI	Class II	Active
Vista®-S	06-401-05101	FDA UDI	Class II	Active
Trabecular Metal™	00-5452-013-51	FDA UDI	Class II	Active
Trabecular Metal™	00-4894-062-30	FDA UDI	Class II	Active
Trabecular Metal™	06-165-02081	FDA UDI	Class II	Active
TM Ardis® Trabecular Metal™	06-701-05111	FDA UDI	Class II	Active
Trabecular Metal™	06-115-00331	FDA UDI	Class II	Active
Vista®-S	06-402-06111	FDA UDI	Class II	Active
Trabecular Metal™	06-131-10092	FDA UDI	Class II	Active
Trabecular Metal™	00-4894-054-15	FDA UDI	Class II	Active
Mergence™-S	96-108-47041	FDA UDI	Class II	Active
Vista®-S	06-401-03061	FDA UDI	Class II	Active
Bigliani/Flatow® Trabecular Metal™	00-4326-040-00	FDA UDI	Class II	Active
Vista®-S	06-402-05061	FDA UDI	Class II	Active
Mergence™-S	96-108-30121	FDA UDI	Class II	Active
Vista®-S	06-401-04041	FDA UDI	Class II	Active
Trabecular Metal™	00-5452-013-72	FDA UDI	Class II	Active
Vista®-S	06-401-05081	FDA UDI	Class II	Active
Trabecular Metal™	06-115-00291	FDA UDI	Class II	Active
Trabecular Metal™	06-115-10571	FDA UDI	Class II	Active
Trabecular Metal™	00-5451-019-30	FDA UDI	Class II	Active

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FDA Recalls (11)

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
Feb 1, 2019	Z-1006-2019	—	terminated	Potentially comingled, resulting in the product in the box potentially not matching the product on the label
Feb 1, 2019	Z-1005-2019	—	terminated	Potentially comingled, resulting in the product in the box potentially not matching the product on the label
Jul 7, 2016	Z-1892-2017	—	terminated	This field action is being initiated following the firm's discovery of a procedural error in the approval of literature resulting in the undo release of certain content. Information was disseminated to distributors and sales representatives during the 2016 National Sales Meeting held February 17-21, 2016.
Apr 15, 2016	Z-1950-2016	—	terminated	Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
Apr 15, 2016	Z-1955-2016	—	terminated	Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
Apr 15, 2016	Z-1953-2016	—	terminated	Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
Apr 15, 2016	Z-1952-2016	—	terminated	Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
Apr 15, 2016	Z-1954-2016	—	terminated	Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
Apr 15, 2016	Z-1951-2016	—	terminated	Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
Feb 4, 2015	Z-1325-2015	—	terminated	One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.
Dec 2, 2014	Z-0851-2015	—	terminated	During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.