10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Reported: November 26, 2014 Initiated: October 29, 2014 #Z-0219-2015
Product Description
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Reason for Recall
The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
Details
- Recalling Firm
- Synthes, Inc.
- Units Affected
- 6
- Distribution
- US Distribution in the states of: AK, FL, OH, OK, and TX.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur. Recalled by Synthes, Inc.. Units affected: 6.
Why was this product recalled? ▼
The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2014. Severity: Moderate. Recall number: Z-0219-2015.
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