Class II — OrthoPediatrics Corp
| Recalling firm | ORTHOPEDIATRICS, CORP |
|---|---|
| Registered facility | ORTHOPEDIATRICS, CORP (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | 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. |
| Quantity | 68 |
| Distribution | Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT. |
| Initiated | 2013-07-24 |
| Classified | 2013-08-09 |
| Terminated | 2013-08-26 |
| Recall number | Z-1941-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — OrthoPediatrics Corp (Z-1941-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65828/
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