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.
Hazard
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.
What You Should Do
Remedy
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.
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Products
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.
- Brand
- OrthoPediatrics Corp
- UPC
- Part number 00-0903-2510, Lot number 150192-J
Units Affected
5