Recall Z-2737-2014 ยท GFC Driver, Surgical, Pin
Zimmer, Inc.
Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.
| Date | Sep 30, 2014 (initiated Sep 9, 2014) |
| Status | Terminated |
| Reason | The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver. |
| Root cause | Device Design |
| Action | Zimmer sent an URGENT MEDICAL DEVICE RECALL notifications dated September 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Review the notification and the updated portion of the Persona surgical technique provided in Attachment 1, and ensure affected personnel are aware of the contents. 2. Locate and quarantine any affected product listed above and notify your Zimmer sales representative. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. If after reviewing this noti |
| Quantity | 16,380 units |
| Distribution | Nationwide Distribution including the states of : HI, CA, UT, NY, OH, IN, AL, FL, GA, WI, IA, MN, NE, SD, NJ, PA, ND, IL, MO, VA, MD, NC, MI, OR, WA, KS, KY, TN, WV, OK, CT, MA, ME, AZ, NM, TX, LA, ID, CO, MT, UT, NV and AK., and Internationally to Singapore, Japan, Germany and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.