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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 9 of 18

Device	Model / Reference	Registries	Class	Status
Nexgen® Trabecular Metal™	00-5445-054-41	FDA UDI	Class II	Active
Trabecular Metal™	06-102-01081	FDA UDI	Class II	Active
Trabecular Metal™	06-155-00271	FDA UDI	Class II	Active
Mergence™-S	96-108-40111	FDA UDI	Class II	Active
Nexgen® Trabecular Metal™	00-5490-035-20	FDA UDI	Class II	Active
Trabecular Metal™	00-5451-017-30	FDA UDI	Class II	Active
Mergence™-S	96-108-03001	FDA UDI	Class I	Active
Vista®-S	06-402-03091	FDA UDI	Class II	Active
Mergence™-S	96-299-50011	FDA UDI	Class I	Active
Mergence™-S	96-101-06101	FDA UDI	Class II	Active
Vista®-S	06-401-06121	FDA UDI	Class II	Active
Mergence™-S	96-108-47051	FDA UDI	Class II	Active
Nexgen® Trabecular Metal™	00-5447-056-31	FDA UDI	Class II	Active
TM Ardis® Trabecular Metal™	06-701-04121	FDA UDI	Class II	Active
Vista®-S	06-401-04071	FDA UDI	Class II	Active
Mergence™-S	96-102-04051	FDA UDI	Class II	Active
Mergence™-S	96-101-02091	FDA UDI	Class I	Active
TM Ardis®	96-701-21081	FDA UDI	Class I	Active
Mergence™-S	96-108-37101	FDA UDI	Class I	Active
Trabecular Metal™	00-5451-067-20	FDA UDI	Class I	Active
Mergence™-S	96-108-60071	FDA UDI	Class II	Active
Nexgen® Trabecular Metal™	00-5490-036-23	FDA UDI	Class II	Active
Mergence™-S	96-102-05071	FDA UDI	Class II	Active
Mergence™-S	96-108-10121	FDA UDI	Class II	Active
Mergence™-S	96-102-02051	FDA UDI	Class II	Active
Vista®-S	06-401-02071	FDA UDI	Class II	Active
Trabecular Metal™	06-166-01081	FDA UDI	Class II	Active
Mergence™-S	96-101-01061	FDA UDI	Class II	Active
Trabecular Metal™	06-115-10591	FDA UDI	Class II	Active
Nexgen® Trabecular Metal™	00-5445-055-46	FDA UDI	Class II	Active
Trabecular Metal™	06-131-10082	FDA UDI	Class II	Active
Nexgen® Trabecular Metal™	00-5490-034-20	FDA UDI	Class II	Active
Mergence™-S	96-102-02071	FDA UDI	Class I	Active
TM Ardis® Trabecular Metal™	06-701-04131	FDA UDI	Class II	Active
Nexgen®	00-5877-010-19	FDA UDI	Class I	Active
Mergence™-S	96-108-67091	FDA UDI	Class II	Active
Vista®-S	06-401-02061	FDA UDI	Class II	Active
Mergence™-S	96-101-02071	FDA UDI	Class II	Active
Explant™	00-7051-056-00	FDA UDI	Class I	Active
Mergence™-S	96-108-60081	FDA UDI	Class II	Active
Mergence™-S	96-299-52011	FDA UDI	Class I	Active
Nexgen® Trabecular Metal™	00-5444-052-36	FDA UDI	Class II	Active
TM Ardis® Trabecular Metal™	06-701-02091	FDA UDI	Class II	Active
Trabecular Metal™	06-131-10302	FDA UDI	Class II	Active
Trabecular Metal™	06-101-01111	FDA UDI	Class II	Active
Mergence™-S	96-102-05121	FDA UDI	Class II	Active
Trabecular Metal™	06-115-10441	FDA UDI	Class II	Active
Nexgen® Trabecular Metal™	00-5444-057-46	FDA UDI	Class II	Active
Trabecular Metal™	06-101-02111	FDA UDI	Class II	Active
Trabecular Metal™	00-5451-013-61	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.