Recall Z-0219-2015
Synthes, Inc. · initiated October 29, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
Codes / lots: part number: 456.316S, lot number: 7782247
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.
FDA-determined 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.
Details
- Recall number
- Z-0219-2015
- Initiated
- October 29, 2014
- Posted by FDA
- November 14, 2014
- Terminated
- December 18, 2015
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 6
- Distribution
- US Distribution in the states of: AK, FL, OH, OK, and TX.
- Recalling firm
- Synthes, Inc., West Chester, PA