Skip to content

Orthovita, Inc.

Also registered as Orthovita Co.

United StatesFDA applicant, unverified

Devices
26
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue26

Newest first, rows 1-26 of 26

Search and filter all 26 devices
Skip device list

Rows 1-26 of 26

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2011

    • 31 Mar 2011 Z-3188-2011 Unclassified (pre-2012) Terminated Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. This abrasion may cause small holes or tears in the packaging material, which may not be immediately visible to the user. Although t the Cortoss(TM) Delivery Gun is provided in double pouches and there have been no report Distribution: Product was distributed within the US to medical facilities in AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY,…
      Full distribution text Product was distributed within the US to medical facilities in AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NH, NJ, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, and WI. Government accounts include Bethesda Naval Center, 8901 Rockville Pike, Bethesda, MD; Lackland Air Force Base, 2200 Berquist Drive, Suite 1, Lackland AFB, TX; Hunter Holmes McGuire VA Hospital 1201 Broad Rock Blvd., Richmond, VA; Madigan Army Medical Center, Madigan Army Medical Center, Tacoma, WA; Ralph H. Johnson VA Medical Center, 109 Bee Street, Charleston, SC; VA Medical Center, 1481 W. 10th St., Indianapolis, IN; VA Hospital of Palo Alto, 3801 Miranda Ave., Palo Alto, CA; VA Loma Linda Healthcare System, 11201 Benton Street, Loma Linda, CA; and VA Medical Center/NY Harbor Healthcare, NY, NY.
      Submission number: K080108

Frequently asked questions

How many devices does Orthovita, Inc. have in the registry?

The registry currently lists 26 devices for Orthovita, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Orthovita, Inc.'s devices?

Among its 26 most recently registered devices, Orthovita, Inc. has devices listed in FDA 510(k) (26 devices).

What risk classes do Orthovita, Inc.'s devices fall under?

Among its 26 most recently registered devices, the classes recorded for Orthovita, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Orthovita, Inc.?

FDA recall records list 1 recall initiated by Orthovita, Inc., the most recent initiated on 31 Mar 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 Orthovita, Inc. in the registry?

The most recently registered devices listed for Orthovita, Inc. include CORTOSS BONE AUGMENTATION MATERIAL, ORTHOVITA PEEK SPACER, ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT and FM-02 BONE GRAFT SUBSTITUTE.

Generated automatically from registry data and not verified by a human reviewer.