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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 14 of 18
DeviceModel / ReferenceRegistriesClassStatus
Vista®-S 06-401-01061
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5446-054-46
FDA UDI
Class IIActive
Trabecular Metal™ 00-5451-013-51
FDA UDI
Class IIActive
Mergence™-S 96-101-05061
FDA UDI
Class IIActive
Trabecular Metal™ 00-4894-001-15
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5490-036-20
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5447-056-41
FDA UDI
Class IIActive
Vista®-S 06-401-01081
FDA UDI
Class IIActive
Vista®-S 06-402-01071
FDA UDI
Class IIActive
Mergence™-S 96-108-67051
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5490-033-01
FDA UDI
Class IIActive
Mergence™-S 96-101-01101
FDA UDI
Class IIActive
Vista®-S 06-402-02071
FDA UDI
Class IIActive
Trabecular Metal™ 06-165-04101
FDA UDI
Class IIActive
Mergence™-S 96-101-05041
FDA UDI
Class IIActive
Trabecular Metal™ 06-166-01161
FDA UDI
Class IIActive
Mergence™-S 96-299-50021
FDA UDI
Class IActive
Trabecular Metal™ 00-5451-059-21
FDA UDI
Class IActive
Trabecular Metal™ 00-4894-066-30
FDA UDI
Class IIActive
Mergence™-S 96-102-01101
FDA UDI
Class IActive
Mergence™-S 96-108-60111
FDA UDI
Class IIActive
Trabecular Metal™ 00-5451-013-67
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5445-056-31
FDA UDI
Class IIActive
Trabecular Metal™ 00-5452-013-46
FDA UDI
Class IActive
Mergence™-S 96-102-03101
FDA UDI
Class IIActive
Mergence™-S 96-101-04091
FDA UDI
Class IIActive
Mergence™-S 96-108-20041
FDA UDI
Class IActive
Mergence™-S 96-108-27121
FDA UDI
Class IActive
Nexgen® Trabecular Metal™ 00-5447-056-46
FDA UDI
Class IIActive
Trabecular Metal™ 00-5451-017-31
FDA UDI
Class IActive
Trabecular Metal™ 00-5452-013-41
FDA UDI
Class IIActive
Mergence™-S 96-102-03081
FDA UDI
Class IIActive
Nexgen® 00-5879-067-41
FDA UDI
Class IActive
Trabecular Metal™ 06-155-00421
FDA UDI
Class IIActive
Trabecular Metal™ 06-131-10552
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5446-053-31
FDA UDI
Class IIActive
Vista®-S 06-401-05051
FDA UDI
Class IIActive
Nexgen® Trabecular Metal™ 00-5490-036-02
FDA UDI
Class IIActive
Trabecular Metal™ 00-5452-017-00
FDA UDI
Class IActive
Vista®-S 06-402-06051
FDA UDI
Class IIActive
Trabecular Metal™ 00-5450-059-21
FDA UDI
Class IIActive
Mergence™-S 96-102-05081
FDA UDI
Class IIActive
Trabecular Metal™ 00-5452-013-30
FDA UDI
Class IIActive
Vista®-S 06-401-02091
FDA UDI
Class IIActive
Mergence™-S 96-102-04091
FDA UDI
Class IIActive
Trabecular Metal™ 00-1197-080-10
FDA UDI
Class IIActive
Vista®-S 06-402-03111
FDA UDI
Class IIActive
Trabecular Metal™ 06-115-00241
FDA UDI
Class IIActive
Vista®-S 06-401-01071
FDA UDI
Class IIActive
Explant™ 00-7051-066-00
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

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.