OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour… recallZ-2057-2012 · OrthoPediatrics Corp · initiated Jun 14, 2012
Class II Terminated All recalls posted in July 2012
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 device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
FDA root cause category: Error in labeling
What the company is doing
On 15-June-2012, a follow-up, URGENT Recall of MIS-BRANDED PediLoc Locking Plate e-mail was sent to all Distributors and direct representatives to provide them with a written notification of the voluntary recall. The e-mail identified the affected product and the reason for the recall. It also instructed them to quarantine all identified devices from the affected lot number immediately. A certified Voluntary Recall notice was also sent as a follow up along with a return prepaid pouch for the return of the recalled device(s) and Mandatory Reply Form.
Recall details
- Recall number
- Z-2057-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 14, 2012
- Posted by the FDA
- Jul 20, 2012
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 15 devices
- Product code
- HRS
- FDA submissions
- K083286
- Distribution
- Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
Product description
OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
Code information (models, lots, serial numbers)
Lot number: 7736703 and part number: 00-1050-4308
Other devices under the same FDA submission
1 device cleared under K083286 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PediLoc Locking Plate System 00-1050-3210Orthopediatrics 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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