—#139919

Product

Zimmer Guide Wires for orthopedic procedures.

FDA product code: FZX — Guide, Surgical, Instrument
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 00-2228-024-00 2.4MM Diameter Bullet Tip Guide Wire; 00-2255-025-00 Humeral Smooth Guide Wire 2.4mm 70cm Length; 00-2255-026-00 Humeral Bullet Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2237-033-00 Smooth Guide Wire 2.4mm Diameter 100cm Length; 47-2237-037-00 3.0MM Diameter Smooth Guide Wire 100cm Length; 47-2237-038-00 Bullet Tip Guide Wire 3.0mm Diameter 100cm Length; 47-2255-008-00 Ball Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2255-008-01 Ball Tip Guide Wire 3.0mm Diameter 100cm Length All non-expired, distributed lots with a 10 year expiration date on the label.

Why it was recalled

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.

Root cause (FDA determination)

Package design/selection

Action the firm took

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).

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: 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, Denmark, Bahamas, Egypt, Panama, Finland, Dominican Republic, France, Guatemala, Germany, Australia, Ireland, Japan,Italy, Haiti, Jordan, Malaysia, Kenya, India, Lebanon, Luxembourg, Malta, Mauritius, Morocco, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, United Kingdom and United Arab Emirates.

Timeline

Recall initiated: 2015-08-27
Posted by FDA: 2015-09-30
Terminated: 2016-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #139919. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.