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ENDOTEC, INC.

US

Last updated May 23, 2026

Information

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

Catalogue (580)

Page 9 of 12
DeviceModel / ReferenceRegistriesClassStatus
B-P Total Shoulder System 02-04-0344
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0613
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0023
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0166
FDA UDI
Class IIActive
B-P Total Hip System 01-17-2846
FDA UDI
Class IIActive
B-P Total Knee System 04-31-2106
FDA UDI
Class IIUnknown
B-P Total Hip System 01-16-0520
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0310
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0611
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0610
FDA UDI
Class IIActive
B-P Total Shoulder System 02-01-0003
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-03-0048
FDA UDI
Class IIActive
B-P Total Knee System 04-31-1103
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0315
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-02-0352
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-15-0603
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0316
FDA UDI
Class IIActive
B-P Total Knee System 04-33-0125
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0016
FDA UDI
Class IIUnknown
B-P Total Hip System 01-04-0111
FDA UDI
Class IIActive
B-P Total Hip System 01-04-0415
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0426
FDA UDI
Class IIUnknown
B-P Total Knee System 04-34-0005
FDA UDI
Class IIUnknown
B-P Total Hip System 01-02-4962
FDA UDI
Class IIUnknown
B-P Total Knee System 04-33-0131
FDA UDI
Class IIActive
B-P Total Hip System 01-14-0128
FDA UDI
Class IIUnknown
B-P Total Hip System 01-16-0114
FDA UDI
Class IIUnknown
B-P Total Hip System 01-01-0568
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0623
FDA UDI
Class IIUnknown
B-P Total Knee System 04-34-0004
FDA UDI
Class IIUnknown
B-P Total Knee System 04-31-2304
FDA UDI
Class IIUnknown
B-P Total Knee System 04-33-0104
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-02-2352
FDA UDI
Class IIActive
B-P Total Knee System 04-33-0144
FDA UDI
Class IIUnknown
B-P Total Hip System 01-01-0060
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0215
FDA UDI
Class IIUnknown
B-P Total Hip System 01-34-0532
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0412
FDA UDI
Class IIUnknown
B-P Total Hip System 01-17-3251
FDA UDI
Class IIUnknown
B-P Total Knee System 04-31-1505
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0515
FDA UDI
Class IIActive
B-P Total Knee System 04-34-0606
FDA UDI
Class IIUnknown
B-P Total Knee System 04-31-2302
FDA UDI
Class IIUnknown
B-P Total Hip System 01-16-0213
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0510
FDA UDI
Class IIActive
B-P Total Knee System 04-31-1101
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0126
FDA UDI
Class IIActive
B-P Total Hip System 01-02-3254
FDA UDI
Class IIUnknown
B-P Total Hip System 01-14-1032
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0802
FDA UDI
Class IIUnknown

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.