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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 18 of 18

Device	Model / Reference	Registries	Class	Status
Mergence™-S	96-101-01041	FDA UDI	Class I	Active
Mergence™-S	96-299-51011	FDA UDI	Class I	Active
Explant™	00-7051-064-00	FDA UDI	Class I	Active
Mergence™-S	96-102-01081	FDA UDI	Class II	Active
Mergence™-S	96-102-01111	FDA UDI	Class II	Active
Mergence™-S	96-101-01121	FDA UDI	Class II	Active
TM Ardis® Trabecular Metal™	06-701-03161	FDA UDI	Class II	Active
Mergence™-S	96-108-30061	FDA UDI	Class II	Active
Mergence™-S	96-299-50001	FDA UDI	Class I	Active
Mergence™-S	96-108-60051	FDA UDI	Class II	Active
Mergence™-S	96-108-10061	FDA UDI	Class I	Active
Mergence™-S	96-101-02061	FDA UDI	Class I	Active
Mergence™-S	96-108-60041	FDA UDI	Class II	Active
TM Ardis® Trabecular Metal™	06-701-04161	FDA UDI	Class II	Active
Mergence™-S	96-101-01111	FDA UDI	Class II	Active
Mergence™-S	96-108-57041	FDA UDI	Class II	Active
Mergence™-S	96-101-01071	FDA UDI	Class II	Active
Bigliani/Flatow® Trabecular Metal™	00-4326-046-00	FDA UDI	Class II	Active
Mergence™-S	96-108-20051	FDA UDI	Class I	Active
Mergence™-S	96-108-37091	FDA UDI	Class II	Active
Mergence™-S	96-101-06121	FDA UDI	Class II	Active
Mergence™-S	96-108-57121	FDA UDI	Class II	Active
Explant™	00-7051-058-00	FDA UDI	Class I	Active
Explant™	00-7051-004-00	FDA UDI	Class I	Active
Mergence™-S	96-299-55011	FDA UDI	Class II	Active
Mergence™-S	96-101-04101	FDA UDI	Class II	Active
Mergence™-S	96-101-01051	FDA UDI	Class I	Active
Explant™	00-7051-054-00	FDA UDI	Class I	Active
Mergence™-S	96-108-47061	FDA UDI	Class II	Active
Mergence™-S	96-108-20111	FDA UDI	Class II	Active
Explant™	00-7051-070-00	FDA UDI	Class I	Active
Mergence™-S	96-299-53011	FDA UDI	Class II	Active
Vista-S Device, Associated Instrumentation	K133784	FDA 510(k)	Class II	Active
Vista -s Device	K070382	FDA 510(k)	Class II	Active
Trabecular Metal Tibial Cone Augments	K102896	FDA 510(k)	Class II	Active
Trabecular Metal Vertebral Body Replacement (vbr), Model# 06-115, 06-155	K070754	FDA 510(k)	Class II	Active
Trabecular Metal Fusion Device Model 06-101-Xxxxx, 06-102-Xxxxx And 08-100-Xxxxx	K103033	FDA 510(k)	Class II	Active
Tm Ardis Interbody System Inserter	K123602	FDA 510(k)	Class II	Active
Vista-S Device Model 08/06-401-Xxxxx, 08/06-402-Xxxxxx	K111983	FDA 510(k)	Class II	Active
Trabecular Metal Femoral Cone Augments	K103517	FDA 510(k)	Class II	Active
Tm-400 Device	K120203	FDA 510(k)	Class II	Active
Tm Ardis Interbody System Tm Ardis Interbody System Instrumenation	K113561	FDA 510(k)	Class II	Active
Trabecular Metal (tm) Vertebral Body Replacement (vbr) System Instrument Set	K093127	FDA 510(k)	Class II	Active
Trabecular Metal Glenoid- B/F Complete Shoulder Solution	K071090	FDA 510(k)	Class II	Active
Nexgen Lcck Trabecular Metal (tm) Coupled Tibial Cones Provisionals To Nexgen Lcck Trabecular Metal (tm) Coupled Tibial	K120990	FDA 510(k)	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.