TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
Reported: May 20, 2015 Initiated: April 9, 2015 #Z-1600-2015
Product Description
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
Reason for Recall
TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.
Details
- Recalling Firm
- Synthes, Inc.
- Units Affected
- 8175
- Distribution
- Distribution US Nationwide and Switzerland.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.. Recalled by Synthes, Inc.. Units affected: 8175.
Why was this product recalled? ▼
TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 20, 2015. Severity: Moderate. Recall number: Z-1600-2015.
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