3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
This recall has been terminated (originally issued September 18, 2015).
- Company
- Orthopediatrics Corp
- Recall Initiated
- July 28, 2015
- Posted
- September 18, 2015
- Terminated
- March 17, 2016
- Recall Number
- Z-2796-2015
- Quantity
- 5
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.
Distribution
Domestic: TN, IA Foreign: England VA/DOD: None
Lot / Code Info
Part number 00-0903-2510, Lot number 150192-J
Root Cause
Packaging process control
Action Taken
OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2510, 3.5mm Non Locking Cortical Screw, Lot # 150192-J, initially by contacting customers via telephone, and then by e-mailing notification letters on 7/28/2015. Customers returned the 5 mislabled screws, which were repacked with correct labeling. All recall activities were complete as of 8/14/2015.