Recall Z-0869-2013 ยท FWZ Operating Room Accessories Table Tray
Integra LifeSciences Corp.
MAYFIELD Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD Base Units are intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is requ
| Date | Feb 21, 2013 (initiated Dec 21, 2012) |
| Status | Terminated |
| Reason | Integra determined there is a possibility that the Base Units may break during use. |
| Root cause | Device Design |
| Action | Integra LifeSciences Corporation sent an Urgent Medical Device Recall letter dated December 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using the affected product immediately and also remove them from service to prevent any further use of the affected product. Integra would provide an alternative base unit to replace those customers could no longer use. Customers were asked to complete the Recall Acknowledgement and Return Form to ensure they received this information. F |
| Quantity | 96 units |
| Distribution | Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA & WI. Internationally to Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.