Z-2057-2012Class II

OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right...

Name: Z-2057-2012 OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right...
Creator: OrthoPediatrics Corp
Published: 2012-06-14
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2012-06-14 / Terminated / root cause: labeling and UDI

FDA source

OrthoPediatrics Corp began a recall of OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic... on 2012-06-14. FDA classified it as Class II and gives the reason as "The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2057-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-14
Posted: 2012-07-20
Terminated: 2013-04-30
Recalling firm: Orthopediatrics Corp
Product: OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On 15-June-2012, a follow-up, URGENT Recall of MIS-BRANDED PediLoc Locking Plate e-mail was sent to all Distributors and direct representatives to provide them with a written notification of the voluntary recall. The e-mail identified the affected product and the reason for the recall. It also instructed them to quarantine all identified devices from the affected lot number immediately. A certified Voluntary Recall notice was also sent as a follow up along with a return prepaid pouch for the return of the recalled device(s) and Mandatory Reply Form.
Quantity in commerce: 15 devices
Distribution: Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
Product codes and lots: Lot number: 7736703 and part number: 00-1050-4308

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2057-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2057-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-20

Product code HRS

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

Process control is the most common named cause of a device recall11 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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)