3.2mm Drill Bit. This is a component within the PediLoc… recallZ-1941-2013 · OrthoPediatrics Corp · initiated Jul 24, 2013
Class II Terminated All recalls posted in August 2013
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 has initiated a voluntary recall of Part # 01-1050-002, 2.5mm Drill Bit, Lot #91300335. Only drill bits that are in their original packaging are being recalled. The description on the package of this drill bit has a wrong size in the description (3.2mm). The recall affects only packaged devices still in original packaging due to misbranding of the product. The drill bit itself has
FDA root cause category: Process design
What the company is doing
On 7/24/13, OrthoPediatrics notified their consignees of this URGENT MEDICAL DEVICE RECALL via phone call. A follow-up email message was then sent with the recall notification, and then a hard copy of the notice was sent via certified letter. The notification addresses the affected product, recall issue, reply form instructions, and directs consignees to return affected product to OrthoPediatrics via a Fed-Ex return prepaid pouch. The firm directs consignees to forward the notification and reply form if the product was further distributed.
Recall details
- Recall number
- Z-1941-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 24, 2013
- Posted by the FDA
- Aug 9, 2013
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 68
- Product code
- HWC
- FDA submissions
- K083286
- Distribution
- Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
Product description
3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in bone prior to placement of a bone screw.
Code information (models, lots, serial numbers)
LOT 91300335 - Catalogue Number 01-1050-0002
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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