Recall Z-2381-2012 ยท FZX Guide, Surgical, Instrument
Integra Life Sci.
The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis, Uni-CP, Advansys MLP and Adv
| Date | Sep 14, 2012 (initiated Jun 14, 2012) |
| Status | Terminated |
| Reason | Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guides during use. None of the complaints resulted in patient injuries but in some cases resulted in an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that any potential for risk would be transient, self-limiting or minor, or result |
| Root cause | Device Design |
| Action | Integra sent a "SUBJECT: MEDICAL DEVICE RECALL" letter dated June 14, 2012 to all affected customers. The letter identified the product, problem, and action to be taken by the customers. Customers were asked to complete a Recall Acknowledgement and Return Form whether or not they were affected by the recall, and return all their affected inventory to Integra LifeSciences. Customers were asked to contact their regional managers or the firm at 609-936-6832 for questions regarding the recall. |
| Quantity | 2,389 units, Catalogue No. 219635ND; 2.7mm Drilling Guides |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Austria, Czech republic, Denmark, France, Germany, Ireland, Israel, Ita |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.