3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Reported: November 30, 2016 Initiated: October 3, 2016 #Z-0640-2017
Product Description
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Reason for Recall
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 319 units
- Distribution
- Distributed Nationwide
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile. Recalled by Synthes (USA) Products LLC. Units affected: 319 units.
Why was this product recalled? ▼
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 30, 2016. Severity: Moderate. Recall number: Z-0640-2017.
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