FDA Device recall Z-2796-2015
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
- FDA Device
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of 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 by Orthopediatrics, citing 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 e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2796-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-28 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthopediatrics |
| Distribution | IA, TN, VA |
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.
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.
Identifiers
| code_info | Part number 00-0903-2510, Lot number 150192-J |
|---|
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-2796-2015%22
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