3.5mm Non Locking Cortical Screw, in the PediLoc Tibial… recallZ-2796-2015 · OrthoPediatrics Corp · initiated Jul 28, 2015
Class II Terminated All recalls posted in September 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from OrthoPediatrics Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging process control
What the company is doing
OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2510, 3.5mm Non Locking Cortical Screw, Lot # 150192-J, initially by contacting customers via telephone, and then by e-mailing notification letters on 7/28/2015. Customers returned the 5 mislabled screws, which were repacked with correct labeling. All recall activities were complete as of 8/14/2015.
Recall details
- Recall number
- Z-2796-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 28, 2015
- Posted by the FDA
- Sep 18, 2015
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 5
- Product code
- HRS
- FDA submissions
- K111086
- Distribution
- Domestic: TN, IA Foreign: England VA/DOD: None
Product description
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.
Code information (models, lots, serial numbers)
Part number 00-0903-2510, Lot number 150192-J
Other devices under the same FDA submission
6 devices cleared under K111086 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Locking Proximal Femur Plate System 00-0907-2104Orthopediatrics Corp. · PLATE, FIXATION, BONE1 report
- Locking Proximal Femur Plate System 00-0907-2204Orthopediatrics Corp. · PLATE, FIXATION, BONE1 report
- Locking Proximal Femur Plate System 00-0907-3205Orthopediatrics Corp. · PLATE, FIXATION, BONE1 report
- LPF, LCB 00-0907-4670Orthopediatrics Corp. · Screw, fixation, bone1 report
- Locking Proximal Femur Plate System 00-0907-4770Orthopediatrics Corp. · Screw, fixation, bone1 report
- Locking Proximal Femur 00-1050-6004Orthopediatrics Corp. · Plate, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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