Osteotech, Inc.
United StatesFDA applicant, unverified FDA FEI 3002600221
- Devices
- 24
- Registrations
- FDA
- FDA recalls
- 14
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Osteotech, Inc. makes
Osteotech, Inc. makes a range of medical devices, including bone graft systems, such as the Grafton DBM and Grafton Plus DBM Paste, as well as spinal correction systems like the Segmental Spinal Correction System. They also produce devices like the Alloprep System, Graftcage TLX, and Plexur M. Additionally, they offer bone void filler devices and musculoskeletal tissue recovery packs. Their product line includes cannulated screws, such as the Osteotech Navicular and Cancellous Cannulated Screws.
The company's portfolio is regulated under Class I and Class II device classes and is listed in the FDA 510(k) registry. Osteotech, Inc. is based in the US.
Catalogue
Search and filter all 24 devicesCompany details
- FDA FEI number
- 3002600221
- Address
- 201 Industrial Way West, EATONTOWN, NJ, 07724
FDA recalls
FDA recall records list 14 recalls initiated by Osteotech, Inc., the earliest on 2011-08-08 and the most recent on 2012-04-20. By recorded status: 14 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 20 Apr 2012 Z-0083-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
- 20 Apr 2012 Z-0084-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
- 20 Apr 2012 Z-0085-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
- 20 Apr 2012 Z-0086-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
- 20 Apr 2012 Z-0087-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
- 20 Apr 2012 Z-0088-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
- 20 Apr 2012 Z-0089-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
- 20 Apr 2012 Z-0090-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
- 20 Apr 2012 Z-0091-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
- 20 Apr 2012 Z-0092-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
Show all 14 recalls
2012
- 20 Apr 2012 Z-0093-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
- 20 Apr 2012 Z-0094-2013 Class II Terminated Multiple lots of GRAFTON and XPANSE , which are used for bone grafting procedures are being recalled because there is a possibility that sterility of the outer surface of the inner pouch may become compromised.
2011
- 8 Aug 2011 Z-0415-2012 Unclassified (pre-2012) Terminated Aseptic conditions during the production of these products may have been compromised.
- 8 Aug 2011 Z-0416-2012 Unclassified (pre-2012) Terminated Aseptic conditions during the production of these products may have been compromised.
Frequently asked questions
How many devices does Osteotech, Inc. have in the registry?
The registry currently lists 24 devices for Osteotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Osteotech, Inc.'s devices?
Among its 24 most recently registered devices, Osteotech, Inc. has devices listed in FDA 510(k) (24 devices).
What risk classes do Osteotech, Inc.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for Osteotech, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Osteotech, Inc.?
FDA recall records list 14 recalls initiated by Osteotech, Inc., the most recent initiated on 20 Apr 2012. 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 Osteotech, Inc. in the registry?
The most recently registered devices listed for Osteotech, Inc. include ALLOPREP SYSTEM, GRAFTCAGE TLX, GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES and GRAFTON PLUS DBM PASTE.