Zimmer Biomet Humeral Guide Wire Recall: Packaging Issue
Zimmer Biomet recalls certain humeral guide wires due to packaging configuration not covering 70cm wires. Affected items were sold before April 2:2022. No action needed as the issue is with packaging, not the product itself.
Lower-risk 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.
Contact the company
What happened, in plain English
Zimmer Biomet is recalling specific humeral guide wires that were packaged in an older configuration. This packaging issue does not affect the product's safety but requires removal from use to prevent potential confusion with the correct packaging. Read more at govinfonow.com/recall/73945-zimmer-biomet-humeral-guide-wire-recall-packaging-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/73945-zimmer-biomet-humeral-guide-wire-recall-packaging-issue · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0547-2018
Cite this page
“Zimmer Biomet Humeral Guide Wire Recall: Packaging Issue.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73945-zimmer-biomet-humeral-guide-wire-recall-packaging-issue. Based on FDA recall #Z-0547-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0547-2018%22&limit=1).
Why it’s dangerous
The packaging configuration for the 70cm guide wires was not verified in the previous version. This means the product was sold without proper design verification, but the actual product is safe for use. The issue only affects how the product is packaged and not its function.
Who’s affected
Medical professionals who use these guide wires for orthopedic procedures may be affected. Patients receiving the product are not at risk as the issue is with packaging, not the product's function.
How to tell if you have this one
Look for the product name 'M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only' with item number 00-2255-025-00. These were sold before April 2022.
- Brand
Zimmer Biomet- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0547-2018 | M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 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.; All Lot Numbers Expiry Date Before April 2022 | 6,290 units |
| Z-0548-2018 | 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.; All Lot Numbers Expiry Date Before March 2022 | 1,517 units |
| Z-0549-2018 | Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 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.; All Lot Numbers Expiry Date Before April 2022 | 7,888 units |
| Z-0550-2018 | Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 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.; All Lot Numbers Expiry Date Before April 2022 | 10,116 units |
| Z-0551-2018 | Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 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.; All Lot Numbers Expiry Date Before March 2022 | 1,631 units |
What to do — step by step
Check Packaging Configuration
Verify the packaging configuration to ensure it matches the current design verification for the 70cm guide wires.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0547-2018 (June 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0547-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.