Recall Z-0934-2014— OrthoPediatrics Corp
Class II · Terminated
Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2014-01-08, terminated 2014-04-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- OrthoPediatrics Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-08
- Terminated
- 2014-04-23
- Firm location
- Warsaw, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.