Device product

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.

Z-2796-2015

July 28, 2015

Class II

Product summary

Firm: OrthoPediatrics Corp
Event: Event 71933
Status: Terminated
Classification: Class II
Quantity: 5
Official record key: device-enforcement:Z-2796-2015

Official wording

Reason: 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.

Code information: Part number 00-0903-2510, Lot number 150192-J

Distribution pattern: Domestic: TN, IA Foreign: England VA/DOD: None

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.