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Terminated

Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.

FDA Recall Z-2737-2014 · Posted 2014-09-30

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeGFC
Date Initiated2014-09-09
Date Terminated2015-05-05
Product Quantity16,380 units

Reason for Recall

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.

Firm 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 notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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