CLASS II Device recall · Reported 2 May 2018 · FDA Enforcement Report
Zimmer Natural Nail System Tear Drop Guide Wire Diameter length recalled
Zimmer Biomet is recalling Zimmer Natural Nail System Tear Drop Guide Wire Diameter length, distributed nationwide in the US. The recall was initiated on 26 Mar 2018 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-1468-2018
- FDA event ID
- 79681
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2018
- FDA classified
- 20 Apr 2018
- Reported
- 2 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 26 Mar 2018 | Recall initiated by company | |
| 20 Apr 2018 | Classified by FDA | +25 days |
| 2 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential failure of sterile packaging seal.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
Where it was distributed
US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
Questions about this recall
Is Zimmer Natural Nail System Tear Drop Guide Wire Diameter length recalled?
Yes. Zimmer Biomet recalled Zimmer Natural Nail System Tear Drop Guide Wire Diameter length on 26 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1468-2018.
Why was it recalled?
Potential failure of sterile packaging seal.
Which lots are affected?
Lot Numbers: 63733044 63748390 63748391 77006546 77006547 77006548
Where was it sold?
US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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