10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
This recall has been terminated (originally issued November 14, 2014).
- Company
- Synthes, Inc.
- Recall Initiated
- October 29, 2014
- Posted
- November 14, 2014
- Terminated
- December 18, 2015
- Recall Number
- Z-0219-2015
- Quantity
- 6
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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.
Distribution
US Distribution in the states of: AK, FL, OH, OK, and TX.
Lot / Code Info
part number: 456.316S, lot number: 7782247
Root Cause
Employee error
Action Taken
An urgent medical device recall notice, dated October 29, 2014, was sent to end users that identified the product, problem and action to be taken. Customers were instructed to return the device to Synthes along with completing the verification section of the notice.