Z-0934-2014 Class II Terminated
FDA device recall Z-0934-2014 was initiated by OrthoPediatrics Corp on January 8, 2014 and is designated Class II. Reason for recall: OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly … The recall status is terminated (terminated April 23, 2014). Affected quantity: 12 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2014
- Initiation Date
- January 8, 2014
- Termination Date
- April 23, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 units
Product Description
3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
Reason for Recall
OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524.
Distribution Pattern
Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.
Code Information
Lot 009SV