Z-1941-2013Class II

3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in...

Name: Z-1941-2013 3.2mm Drill Bit. This is a component within the PediLoc Locking Plate System utilized to pre-drill a hole in...
Creator: OrthoPediatrics Corp
Published: 2013-07-24
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2013-07-24 / Terminated / root cause: manufacturing process

FDA source

OrthoPediatrics Corp began a recall of 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 on 2013-07-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1941-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-24
Posted: 2013-08-09
Terminated: 2013-08-26
Recalling firm: Orthopediatrics Corp
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.
Product code: HWC Screw, Fixation, Bone
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 68
Distribution: Nationwide distribution, including the states of MO, MI, WA, FL, NY, TN, CO, AZ, VA, TX, CA, MN, LA, NC, and UT.
Product codes and lots: LOT 91300335 - Catalogue Number 01-1050-0002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1941-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1941-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-09

Product code HWC

K083286Class IIOrthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. / cleared 2009-01-30

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)