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Zimmer Trabecular Metal Technology, Inc.

US

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
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Catalogue (895)

Page 17 of 18
DeviceModel / ReferenceRegistriesClassStatus
Mergence™-S 96-108-57091
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5490-033-23
FDA UDI
Class IIActive
Mergence™-S 96-108-27091
FDA UDI
Class IIActive
Mergence™-S 96-101-06051
FDA UDI
Class IIActive
Vista®-S 06-401-02101
FDA UDI
Class IIActive
Trabecular Metal™ 00-5452-013-31
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5446-053-36
FDA UDI
Class IIActive
Mergence™-S 96-101-05051
FDA UDI
Class IIActive
Trabecular Metal™ 06-131-20172
FDA UDI
Class IIActive
Mergence™-S 96-105-20001
FDA UDI
Class IActive
Vista®-S 06-402-01101
FDA UDI
Class IIActive
Mergence™-S 96-299-54011
FDA UDI
Class IIActive
Trabecular Metal™ 00-1197-100-10
FDA UDI
Class IIActive
Mergence™-S 96-102-03061
FDA UDI
Class IIActive
Trabecular Metal™ 00-5451-059-00
FDA UDI
Class IActive
Trabecular Metal™ 06-155-00321
FDA UDI
Class IIActive
Nexgen® 00-5879-067-32
FDA UDI
Class IActive
Vista®-S 06-402-04051
FDA UDI
Class IIActive
Mergence™-S 96-108-17041
FDA UDI
Class IIActive
Mergence™-S 96-108-50071
FDA UDI
Class IIActive
Trabecular Metal™ 06-115-10621
FDA UDI
Class IIActive
Mergence™-S 96-102-06121
FDA UDI
Class IIActive
Explant™ 00-7051-001-00
FDA UDI
Class IActive
Nexgen® Trabecular Metal™ 00-5446-052-36
FDA UDI
Class IIActive
Trabecular Metal™ 00-5450-067-21
FDA UDI
Class IIActive
Mergence™-S 96-299-54001
FDA UDI
Class IIActive
Trabecular Metal™ 00-5451-059-20
FDA UDI
Class IActive
Trabecular Metal™ 00-5452-013-07
FDA UDI
Class IIActive
Trabecular Metal™ 00-4894-050-10
FDA UDI
Class IIActive
Trabecular Metal™ 00-5451-013-31
FDA UDI
Class IIActive
Explant™ 00-7051-048-00
FDA UDI
Class IActive
Mergence™-S 96-102-06091
FDA UDI
Class IIActive
TM Ardis® Trabecular Metal™ 06-701-02161
FDA UDI
Class IIActive
TM Ardis® Trabecular Metal™ 06-701-04141
FDA UDI
Class IIActive
Mergence™-S 96-102-02091
FDA UDI
Class IIActive
Trabecular Metal™ 00-4894-001-54
FDA UDI
Class IIActive
Trabecular Metal™ 00-5452-013-56
FDA UDI
Class IIActive
Trabecular Metal™ 06-101-01051
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5444-053-31
FDA UDI
Class IIActive
Nexgen® 00-5879-065-38
FDA UDI
Class IActive
Nexgen® Trabecular Metal™ 00-5444-054-36
FDA UDI
Class IIActive
TM Ardis® Trabecular Metal™ 06-701-02131
FDA UDI
Class IIActive
Mergence™-S 96-108-40081
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5444-055-41
FDA UDI
Class IIActive
TM Ardis® Trabecular Metal™ 06-701-05141
FDA UDI
Class IIActive
Explant™ 00-7052-042-00
FDA UDI
Class IActive
Mergence™-S 96-102-02121
FDA UDI
Class IIActive
Mergence™-S 96-108-27081
FDA UDI
Class IActive
Mergence™-S 96-108-57081
FDA UDI
Class IIActive
Mergence™-S 96-101-02111
FDA UDI
Class IIActive

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Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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.

DateRecall No.ClassStatusReason
Feb 1, 2019Z-1006-2019—terminated

Potentially comingled, resulting in the product in the box potentially not matching the product on the label

Feb 1, 2019Z-1005-2019—terminated

Potentially comingled, resulting in the product in the box potentially not matching the product on the label

Jul 7, 2016Z-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, 2016Z-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, 2016Z-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, 2016Z-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, 2016Z-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, 2016Z-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, 2016Z-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, 2015Z-1325-2015—terminated

One unit of the 20 mm augments was mislabeled as 5 mm and it was subsequently distributed.

Dec 2, 2014Z-0851-2015—terminated

During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.