Z-2843-2016Class II

3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in...

Name: Z-2843-2016 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in...
Creator: OrthoPediatrics Corp
Published: 2016-07-27
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2016-07-27 / Terminated / root cause: labeling and UDI

FDA source

OrthoPediatrics Corp began a recall of 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional... on 2016-07-27. FDA classified it as Class II and gives the reason as "OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled". 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-2843-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-27
Posted: 2016-09-19
Terminated: 2017-03-24
Recalling firm: Orthopediatrics Corp
Product: 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws, PediLoc offers a construct that resists angular collapse while simultaneously acting as an effective aid to fracture reduction.
Product code: HWC Screw, Fixation, Bone
Reason for recall: OrthoPediatrics Corp.is voluntarily recalling multiple lots of the 3.5mm Bowed Locking Compression Femur 14-hole Plate and 18-hole Plate due to the devices being mislabeled.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Orthopediatrics initiated the recall of 3.5mm Bowed Locking Compression Femur Plates by distributing e-mails on 0July 27, 2016, followed by telephone calls to all customers on July 28, 2016. All distributors and direct representatives were sent an e-mail to provide them with a written notification of the voluntary recall and instruct them to quarantine all identified devices from the affected lot numbers immediately. Customers were instructed to quarantine recalled product and response via a hard copy Reply Form that was included in a hard copy of the Recall Notice. Each sales representative was also asked to contact Orthopediatrics Logistics Department to receive a Return Authorization Number for returning recalled product. in order to track their affected plates. If customers have any questions about this recall, they were instructed to reach out to the firm via phone (office: 574-267-0865) or email ([email protected]).
Quantity in commerce: 41
Distribution: Nationwide Distribution to AZ, CA, CO, DE, FL, GA, KY, MI, MN, MO, KY, RI, NY, OH, OR, RI, TN, TX, VA, WA Foreign: None VA/DOD: None
Product codes and lots: Product Number: 00-1050-3214 Lot Number: NM02341 Product Number: 00-1050-3214 Lot Number: NM02342

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2843-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2843-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-19
Z-2844-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-19

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)