3.5mm Bowed Locking Compression Femur Plates, 14 hole recallZ-2843-2016 · OrthoPediatrics Corp · initiated Jul 27, 2016
Class II Terminated All recalls posted in September 2016
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
OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
FDA root cause category: Labeling mix-ups
What the company is doing
Orthopediatrics initiated the recall of 3.5mm Bowed Locking Compression Femur Plates by distributing e-mails on 0July 27, 2016, followed by telephone calls to all customers on July 28, 2016. All distributors and direct representatives were sent an e-mail to provide them with a written notification of the voluntary recall and instruct them to quarantine all identified devices from the affected lot numbers immediately. Customers were instructed to quarantine recalled product and response via a hard copy Reply Form that was included in a hard copy of the Recall Notice. Each sales representative was also asked to contact Orthopediatrics Logistics Department to receive a Return Authorization Number for returning recalled product. in order to track their affected plates. If customers have any questions about this recall, they were instructed to reach out to the firm via phone (office: 574-267-0865) or email ([email protected]).
Recall details
- Recall number
- Z-2843-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 27, 2016
- Posted by the FDA
- Sep 19, 2016
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 41
- Product code
- HWC
- FDA submissions
- K083286
- Distribution
- Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA Foreign: None VA/DOD: None
Product description
3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
Code information (models, lots, serial numbers)
Product Number: 00-1050-3214 Lot Number: NM02341 Product Number: 00-1050-3214 Lot Number: NM02342
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
Other products in the same recall event
The FDA groups related products into one recall event (event 74928).
- Z-2844-2016 · Terminated3.5mm Bowed Locking Compression Femur Plates, 18 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fix…
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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