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ENDOTEC, INC.

US

Last updated May 23, 2026

Information

Country
US
Address
—
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
803488357

Catalogue (580)

Page 6 of 12
DeviceModel / ReferenceRegistriesClassStatus
B-P Total Knee System 04-32-0125
FDA UDI
Class IIActive
B-P Total Knee System 04-33-0123
FDA UDI
Class IIActive
B-P Total Knee System 04-34-0003
FDA UDI
Class IIUnknown
B-P Total Hip System 01-16-0519
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0302
FDA UDI
Class IIUnknown
B-P Total Knee System 04-31-1003
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0413
FDA UDI
Class IIUnknown
B-P Total Knee System 04-31-2502
FDA UDI
Class IIUnknown
B-P Total Hip System 01-16-0612
FDA UDI
Class IIActive
B-P Total Hip System 01-14-0528
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-04-0114
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0809
FDA UDI
Class IIActive
B-P Total Knee System 04-31-1303
FDA UDI
Class IIUnknown
B-P Total Hip System 01-17-3240
FDA UDI
Class IIUnknown
B-P Total Hip System 01-16-0117
FDA UDI
Class IIUnknown
B-P Total Hip System 01-03-0045
FDA UDI
Class IIUnknown
B-P Total Knee System 04-33-0134
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0001
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0413
FDA UDI
Class IIUnknown
B-P Total Hip System 01-17-2841
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0464
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0005
FDA UDI
Class IIUnknown
B-P Total Knee System 04-33-0133
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-02-0444
FDA UDI
Class IIActive
B-P Total Knee System 04-31-1001
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0105
FDA UDI
Class IIActive
B-P Total Hip System 01-17-3252
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0814
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0315
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0416
FDA UDI
Class IIUnknown
B-P Total Knee System 04-31-1504
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-04-0348
FDA UDI
Class IIActive
B-P Total Hip System 01-03-0049
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0121
FDA UDI
Class IIActive
B-P Total Hip System 01-21-0115
FDA UDI
Class IIUnknown
B-P Total Hip System 01-16-0210
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-02-0348
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0418
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-04-0208
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0615
FDA UDI
Class IIUnknown
B-P Total Hip System 01-02-3646
FDA UDI
Class IIUnknown
B-P Total Knee System 04-34-0006
FDA UDI
Class IIUnknown
B-P Total Hip System 01-01-0052
FDA UDI
Class IIActive
B-P Total Shoulder System 02-02-5452
FDA UDI
Class IIActive
B-P Total Hip System 01-02-2860
FDA UDI
Class IIActive
B-P Total Knee System 04-33-0116
FDA UDI
Class IIActive
B-P Total Shoulder System 02-02-2456
FDA UDI
Class IIActive
B-P Total Hip System 01-03-0044
FDA UDI
Class IIUnknown
B-P Total Knee System 04-33-0112
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0311
FDA UDI
Class IIUnknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

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FDA Recalls (20)

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
Sep 21, 2011Z-0441-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0440-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0432-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0433-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0438-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0436-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0434-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0443-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0437-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0435-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0431-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0439-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Sep 21, 2011Z-0442-2012—terminated

On 09/21/2011 Endotec, Orlando, FL initiated a recall for the Beuchel-Pappas Mobile Bearing Knee System (BP Knee). The BP Mobile Bearing Knee System consists of unapproved mobile (rotating) bearing tibial and patellar components.

Jun 5, 2009Z-1622-2010—terminated

Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.

Jun 5, 2009Z-1623-2010—terminated

Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.

Jun 5, 2009Z-1626-2010—terminated

Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.

Jun 5, 2009Z-1621-2010—terminated

Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.

Jun 5, 2009Z-1625-2010—terminated

Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.

Jun 5, 2009Z-1627-2010—terminated

Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.

Jun 5, 2009Z-1624-2010—terminated

Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.