Orthovita(R) Cortoss(TM) Delivery Gun Product Usage: Used for the application of Cortoss(TM) Bone Augmentation Material

FDA device recall Z-3188-2011 · posted 2011-09-12 · Terminated

Recall details

Recalling firm

Orthovita, Inc.

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

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

KIH

Quantity affected

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, T

Date initiated

2011-03-31

Date posted

2011-09-12

Date terminated

2012-09-25

Location

Malvern, PA

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