CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report
M/DN Intramedullary Fixation Humeral Guide Wire recalled
Zimmer Biomet is recalling M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip Diameter Length Single Use, distributed nationwide in the US. The recall was initiated on 5 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0548-2018
- FDA event ID
- 78219
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2017
- FDA classified
- 6 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 5 Jun 2017 | Recall initiated by company | |
| 6 Feb 2018 | Classified by FDA | +246 days |
| 14 Feb 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All Lot Numbers Expiry Date Before March 2022
Where was it sold?
Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 78219This product is part of a recall event; the main page for the event is M/DN Intramedullary Fixation Humeral Guide Wire recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | M/DN Intramedullary Fixation Humeral Guide Wire recalled | Zimmer Biomet | Packaging Defects | Nationwide | |
| CLASS II | Humeral Guide Wire Ball Tip Diameter Length recalled by Zimmer Biomet | Zimmer Biomet | Packaging Defects | Nationwide | |
| CLASS II | Zimmer Natural Nail System Tear Drop Guide Wire Diameter length recalled | Zimmer Biomet | Packaging Defects | Nationwide | |
| CLASS II | Zimmer Natural Nail System Tear Drop Guide Wire Diameter length recalled | Zimmer Biomet | Packaging Defects | Nationwide |
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