FDA Device recall Z-1941-2013
3.2mm Drill Bit
- FDA Device
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of 3.2mm Drill Bit by Orthopediatrics, citing 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. Th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1941-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-24 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthopediatrics |
| Distribution | US |
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.
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
Identifiers
| code_info | LOT 91300335 - Catalogue Number 01-1050-0002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1941-2013%22
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