FDAFDA · Food and drugs·Recall number Z-0640-2017
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Published November 30, 2016 · Recall initiated: October 3, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- Distributed Nationwide
- Lot
- Catalog ID 355.041S, Lot Numbers: H085635; H087271; H094462; H111419; H136756
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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