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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 8 of 18
DeviceModel / ReferenceRegistriesClassStatus
Mergence™-S 96-102-05091
FDA UDI
Class IIActive
Mergence™-S 96-108-17101
FDA UDI
Class IActive
Mergence™-S 96-108-30041
FDA UDI
Class IActive
Mergence™-S 96-101-04061
FDA UDI
Class IIActive
Trabecular Metal™ 06-173-01091
FDA UDI
Class IIUnknown
Explant™ 00-7051-044-00
FDA UDI
Class IActive
Mergence™-S 96-108-10051
FDA UDI
Class IIActive
Mergence™-S 96-102-04101
FDA UDI
Class IIActive
Trabecular Metal™ 06-101-03081
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5490-034-02
FDA UDI
Class IIActive
Trabecular Metal™ 06-136-30151
FDA UDI
Class IIActive
Trabecular Metal™ 06-102-02051
FDA UDI
Class IIActive
Mergence™-S 96-102-05101
FDA UDI
Class IIActive
Explant™ 00-7051-068-00
FDA UDI
Class IActive
Trabecular Metal™ 00-5451-048-01
FDA UDI
Class IActive
Nexgen® 00-5451-007-00
FDA UDI
Class IActive
Vista®-S 06-401-04081
FDA UDI
Class IIActive
Mergence™-S 96-102-03111
FDA UDI
Class IIActive
Trabecular Metal™ 00-7000-058-20
FDA UDI
Class IIActive
Trabecular Metal™ 06-102-02081
FDA UDI
Class IIActive
Trabecular Metal™ 06-101-02051
FDA UDI
Class IIActive
Trabecular Metal™ 00-5451-013-60
FDA UDI
Class IIActive
TM Ardis® 96-701-21121
FDA UDI
Class IActive
TM Ardis® Trabecular Metal™ 06-701-05091
FDA UDI
Class IIActive
Nexgen® 00-5877-011-23
FDA UDI
Class IActive
TM Ardis® Trabecular Metal™ 06-701-03091
FDA UDI
Class IIActive
Bigliani/Flatow® Trabecular Metal™ 00-4326-052-46
FDA UDI
Class IIActive
Trabecular Metal™ 06-155-00451
FDA UDI
Class IIActive
Trabecular Metal™ 06-136-30081
FDA UDI
Class IIActive
Vista®-S 06-401-03091
FDA UDI
Class IIActive
Mergence™-S 96-102-06081
FDA UDI
Class IIActive
Trabecular Metal™ 06-115-00171
FDA UDI
Class IIActive
Trabecular Metal™ 06-131-20112
FDA UDI
Class IIActive
Trabecular Metal™ 06-115-10561
FDA UDI
Class IIActive
Mergence™-S 96-108-50091
FDA UDI
Class IIActive
Trabecular Metal™ 00-5452-013-61
FDA UDI
Class IActive
Nexgen® Trabecular Metal™ 00-5446-056-36
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5444-054-41
FDA UDI
Class IIActive
Trabecular Metal™ 00-1197-120-10
FDA UDI
Class IIActive
Explant™ 00-7051-060-00
FDA UDI
Class IActive
Trabecular Metal™ 00-1197-090-10
FDA UDI
Class IIActive
Mergence™-S 96-102-01051
FDA UDI
Class IIActive
Mergence™-S 96-108-20091
FDA UDI
Class IIActive
Trabecular Metal™ 06-102-02071
FDA UDI
Class IIActive
Mergence™-S 96-105-10001
FDA UDI
Class IActive
Trabecular Metal™ 00-5452-013-60
FDA UDI
Class IIActive
Vista®-S 06-401-04051
FDA UDI
Class IIActive
Mergence™-S 96-101-06091
FDA UDI
Class IIActive
Trabecular Metal™ 06-101-01121
FDA UDI
Class IIActive
Nexgen® 00-5887-051-00
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.