Endotec, Inc.
United StatesFDA applicant, unverified
Endotec, Inc. is a medical device manufacturer, with 580 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and III) and 20 FDA recalls as of 12 Nov 2026.
- Devices
- 580
- FDA recalls
- 20
Registry facts
- Registries
- FDA GUDID 565
- FDA 510(k) 15
- Device classes
- FDA Class II 579
- FDA Class III 1
- FDA recalls
- Identifiers
- DUNS 803488357
At a glance
Market reach
- United States
- FDA recalls
What Endotec, Inc. makes
Endotec, Inc. manufactures orthopaedic implants including cruciate-retaining total knee prostheses, ceramic-on-polyethylene total hip prostheses, bipolar humeral and femoral head components for hemiarthroplasty, total shoulder prostheses, resurfacing humeral and metallic hip prostheses, and non-bioabsorbable orthopaedic bone screws.
The company’s portfolio includes devices regulated as Class II and Class III under FDA requirements, with submissions recorded in the FDA 510(k) and UDI registries.
Catalogue
Search and filter all 580 devicesShowing 1-50 of 580
Company details
- DUNS number
- 803488357
FDA recalls
FDA recall records list 20 recalls initiated by ENDOTEC, INC., the earliest on 2009-06-05 and the most recent on 2011-09-21. By recorded status: 20 terminated. The reasons filed fall into these groups: sterility or contamination and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 21 Sep 2011 Z-0431-2012 Unclassified (pre-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.
- 21 Sep 2011 Z-0432-2012 Unclassified (pre-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.
- 21 Sep 2011 Z-0433-2012 Unclassified (pre-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.
- 21 Sep 2011 Z-0434-2012 Unclassified (pre-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.
- 21 Sep 2011 Z-0435-2012 Unclassified (pre-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.
- 21 Sep 2011 Z-0436-2012 Unclassified (pre-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.
- 21 Sep 2011 Z-0437-2012 Unclassified (pre-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.
- 21 Sep 2011 Z-0438-2012 Unclassified (pre-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.
- 21 Sep 2011 Z-0439-2012 Unclassified (pre-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.
- 21 Sep 2011 Z-0440-2012 Unclassified (pre-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.
Show all 20 recalls
2011
- 21 Sep 2011 Z-0441-2012 Unclassified (pre-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.
- 21 Sep 2011 Z-0442-2012 Unclassified (pre-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.
- 21 Sep 2011 Z-0443-2012 Unclassified (pre-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.
2009
- 5 Jun 2009 Z-1621-2010 Unclassified (pre-2012) 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.
Full distribution text
- 5 Jun 2009 Z-1622-2010 Unclassified (pre-2012) 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.
Full distribution text
- 5 Jun 2009 Z-1623-2010 Unclassified (pre-2012) 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.
Full distribution text
- 5 Jun 2009 Z-1624-2010 Unclassified (pre-2012) 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.
Full distribution text
- 5 Jun 2009 Z-1625-2010 Unclassified (pre-2012) 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.
Full distribution text
- 5 Jun 2009 Z-1626-2010 Unclassified (pre-2012) 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.
Full distribution text
- 5 Jun 2009 Z-1627-2010 Unclassified (pre-2012) 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.
Full distribution text
- 5 Jun 2009 Z-1621-2010 Unclassified (pre-2012) 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.
Frequently asked questions
How many devices does ENDOTEC, INC. have in the registry?
The registry currently lists 580 devices for ENDOTEC, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ENDOTEC, INC.'s devices?
Among its 50 most recently registered devices, ENDOTEC, INC. has devices listed in FDA GUDID (50 devices).
What risk classes do ENDOTEC, INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for ENDOTEC, INC.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ENDOTEC, INC.?
FDA recall records list 20 recalls initiated by ENDOTEC, INC., the most recent initiated on 21 Sep 2011. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from ENDOTEC, INC. in the registry?
The most recently registered devices listed for ENDOTEC, INC. include B-P TOTAL KNEE SYSTEM 04-32-0062, B-P TOTAL HIP SYSTEM 01-16-0814, B-P TOTAL KNEE SYSTEM 04-34-0203 and B-P TOTAL KNEE SYSTEM 04-32-0813.