Z-3188-2011

Orthovita(R) Cortoss(TM) Delivery Gun

Name: Z-3188-2011 Orthovita(R) Cortoss(TM) Delivery Gun
Creator: Orthovita, Inc.
Published: 2011-03-31
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2011-03-31 / Terminated / root cause: packaging

FDA source

Orthovita, Inc. began a recall of Orthovita(R) Cortoss(TM) Delivery Gun Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material on 2011-03-31. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3188-2011
Status: Terminated
Initiated: 2011-03-31
Posted: 2011-09-12
Terminated: 2012-09-25
Recalling firm: DSM Biomedical, Inc.
Product: Orthovita(R) Cortoss(TM) Delivery Gun Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material
Product code: KIH Dispenser, Cement
Reason for recall: 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
Root cause tag: packaging
FDA root cause: Packaging
Action: Orthovita sent an "URGENT FIELD SAFETY NOTICE" letter dated March 31, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to Identify, quarantine and discontinue use of the affected product. The letter included an acknowledgement form to be completed and returned as per instructions.. The letter states that the recalling firm will contact customers to arrange for the return or destruction of any affected product. A pre-paid shipping label is provided for product return. The letter also states that the recalling firm will provide replacement product at no cost. For any questions regarding this notice call 484-323-8860.
Quantity in commerce: 3174
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, 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.
Product codes and lots: Part Number 2110-0008: Lot numbers affected are A812057, A902032, A902063, A904005, A905009, A905039, A906004, A910016, A910021, A912029, A912039, and A1001020. No other lot numbers are affected.

Product code KIH

K080108Class IICortoss Bone Augmentation MaterialOrthovita, Inc. / cleared 2009-06-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)