FDA Device recall Z-0934-2014
3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicat…
- FDA Device
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicat… by Orthopediatrics, citing 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 pa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0934-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-08 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthopediatrics |
| Distribution | CO, FL, KY, LA, MN, MO, OH, OK |
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.
Identifiers
| code_info | Lot 009SV |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0934-2014%22
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