Z-2820-2015Class II

Zimmer Guide Wires for orthopedic procedures

Name: Z-2820-2015 Zimmer Guide Wires for orthopedic procedures
Creator: Zimmer, Inc.
Published: 2015-08-27
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-08-27 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of Zimmer Guide Wires for orthopedic procedures on 2015-08-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2820-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-27
Posted: 2015-09-30
Terminated: 2016-03-15
Recalling firm: Zimmer GmbH
Product: Zimmer Guide Wires for orthopedic procedures.
Product code: FZX Guide, Surgical, Instrument
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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: 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 [email protected]. 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: [email protected]. 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).
Quantity in commerce: 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, 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2820-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2820-2015	Class II	Terminated	Voluntary: Firm initiated	2015-10-07	2015-09-30

Product code FZX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)