Z-0548-2018Class II

M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only...

Name: Z-0548-2018 M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only...
Creator: Zimmer Biomet, Inc.
Published: 2017-06-05
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-06-05 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Product Usage: The Ball... on 2017-06-05. FDA classified it as Class II and gives the reason as "The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result...". 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-0548-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-05
Posted: 2018-02-07
Terminated: 2019-04-17
Recalling firm: Zimmer GmbH
Product: M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On June 5, 2017, Zimmer Biomet distributed Urgent Medical Device Recall notices to their customers via FedEx and email. **Hospital Risk Managers are advised to:** 1. Review this notification and ensure affected team members are aware of the contents. 2. Complete the Certification of Acknowledgement portion of Attachment 1 a. Return a digital copy to [email protected] within three (3) days. 3. Assist your Zimmer Biomet sales representative quarantine all affected product. **Distributors are advised to:** 1. Review this notification and ensure affected personnel are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form a. Return a digital copy to [email protected] within three (3) days. 4. Note that any hospitals that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager directly. It is important that you review the list of hospitals included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals that may have received or used the affected product within the past 12 months. If there are no additional users to notify, please confirm this by annotating and returning the form provided indicating that no additional users have been identified. 5. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks. a. For each return, send a copy of Attachment 1 to [email protected]. b. Include a hardcopy of Attachment 1 with your shipment for i
Quantity in commerce: 1,517 units
Distribution: Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
Product codes and lots: All Lot Numbers Expiry Date Before March 2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0548-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0547-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06
Z-0548-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06
Z-0549-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06
Z-0550-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06
Z-0551-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06

Product code LXH

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)