Zimmer Guide Wires for orthopedic procedures.

FDA device recall Z-2820-2015 · posted 2015-09-30 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.

Action taken

Zimmer sent an "URGENT MEDICAL DEVICE RECALL" notifications dated August 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities: 1.Review the notification and ensure affected personnel are aware of the contents. 2.Locate part number and lot number combinations listed in attachment 1 and quarantine the devices immediately. 3.Carry out a physical count of all affected product in your territory, including hospitals in your territory with direct sales as well as consignment, and complete the Inventory Return Certification of Acknowledgement (Attachment 2). Email a completed copy of Attachment 2 to corporatequality.postmarket@zimmerbiomet.com. 4.Return the recalled product along with the completed Attachment 2. Clearly mark the outside carton of each product return shipment made as Recall. 5.Please notify Zimmer Biomet of any hospitals and surgeons that have consumed the product in the past 12 months that are not included in either the distribution history or inventory system data information. Supply the information for any hospitals and surgeons that you have additionally identified by using the provided spreadsheet Additional Account template. The template, and the list of known consignees from the distribution history and inventory systems data, will be emailed to you for completion and return to: corporatequality.postmarket@zimmerbiomet.com. 6.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 For further questions about this recall, please call ( 1-800-447-5633).

Root cause

Package design/selection

Status

Terminated

Product code

FZX

Quantity affected

112,568 units

Distribution

Worldwide Distribution - US (nationwide) including Puerto Rico and Virgin Islands., and to the countries of Canada, Brazil, Algeria, Mexico, Austria, Taiwan, Belgium, Hong Kong, Croatia, Singapore, De

Date initiated

2015-08-27

Date posted

2015-09-30

Date terminated

2016-03-15

Location

Warsaw, IN