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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 3 of 12
DeviceModel / ReferenceRegistriesClassStatus
B-P Total Knee System 04-32-0025
FDA UDI
Class IIUnknown
B-P Total Hip System 01-17-3246
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0803
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0305
FDA UDI
Class IIActive
B-P Total Hip System 01-17-3249
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-02-2252
FDA UDI
Class IIActive
B-P Total Hip System 01-17-2842
FDA UDI
Class IIActive
B-P Total Shoulder System 02-02-5352
FDA UDI
Class IIUnknown
B-P Total Knee System 04-33-0121
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0662
FDA UDI
Class IIUnknown
B-P Total Knee System 04-31-2202
FDA UDI
Class IIUnknown
B-P Total Hip System 01-34-1532
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-21-0201
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0321
FDA UDI
Class IIUnknown
B-P Total Hip System 01-04-0112
FDA UDI
Class IIUnknown
B-P Total Hip System 01-34-1528
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0414
FDA UDI
Class IIUnknown
B-P Total Knee System 03-12-0012
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0663
FDA UDI
Class IIActive
B-P Total Hip System 01-03-0034
FDA UDI
Class IIUnknown
B-P Total Hip System 01-16-0720
FDA UDI
Class IIUnknown
B-P Total Knee System 04-31-2501
FDA UDI
Class IIUnknown
B-P Total Hip System 01-34-2032
FDA UDI
Class IIActive
B-P Total Shoulder System 02-02-5344
FDA UDI
Class IIActive
B-P Total Hip System 01-17-3242
FDA UDI
Class IIUnknown
B-P Total Hip System 01-02-3256
FDA UDI
Class IIUnknown
B-P Total Hip System 01-04-0110
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0006
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0164
FDA UDI
Class IIUnknown
B-P Total Hip System 01-16-0311
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0421
FDA UDI
Class IIUnknown
B-P Total Knee System 04-31-2505
FDA UDI
Class IIUnknown
B-P Total Knee System 03-12-0036
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0823
FDA UDI
Class IIUnknown
B-P Total Hip System 01-03-0052
FDA UDI
Class IIUnknown
B-P Total Hip System 01-34-0528
FDA UDI
Class IIActive
B-P Total Hip System 01-03-0036
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0401
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0304
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0122
FDA UDI
Class IIActive
B-P Total Hip System 01-01-0058
FDA UDI
Class IIActive
B-P Total Hip System 01-02-3250
FDA UDI
Class IIActive
B-P Total Hip System 01-16-0415
FDA UDI
Class IIUnknown
B-P Total Hip System 01-16-0709
FDA UDI
Class IIUnknown
B-P Total Shoulder System 02-03-0052
FDA UDI
Class IIActive
B-P Total Hip System 01-01-0062
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0405
FDA UDI
Class IIActive
B-P Total Hip System 01-34-2028
FDA UDI
Class IIUnknown
B-P Total Knee System 04-32-0865
FDA UDI
Class IIActive
B-P Total Knee System 04-32-0322
FDA UDI
Class IIActive

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 (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.