Z-0934-2014Class II

3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics...

Name: Z-0934-2014 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics...
Creator: OrthoPediatrics Corp
Published: 2014-01-08
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2014-01-08 / Terminated / root cause: labeling and UDI

FDA source

OrthoPediatrics Corp began a recall of 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures... on 2014-01-08. FDA classified it as Class II and gives the reason as "OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non...". 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-0934-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-08
Posted: 2014-02-06
Terminated: 2014-04-23
Recalling firm: Orthopediatrics Corp
Product: 3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.
Product code: HWC Screw, Fixation, Bone
Reason for recall: OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Orthopediatrics Corporation has requested sales representatives and distributors who have been identified via shipping records as having the possibility of having received one or more discrepant devices affected by this Recall were requested to quarantine the devices identified in this Recall by telephone on January 8, 2014. The decision to Recall these devices was made and a formal written Recall Notice sent to the consignees via email on January 13, 2014. Notification will not be sent to hospitals at this time provided that all devices are retrieved or accounted for within 60 days of the initiation of recall. Hospitals will be notified on an as needed basis if OrthoPediatrics determines that all recalled devices have not been recovered or accounted for, and that contacting the hospitals involved will expedite the recall efforts. All discrepant devices subject to this voluntary Recall are planned to be returned from distribution to OrthoPediatrics Corp. in Warsaw, Indiana and maintained in quarantine. All remaining unshipped devices from these lots have been placed in quarantine at OrthoPediatrics Corp. All quarantined devices at OrthoPediatrics will be inspected and repackaged to correct the mislabeling per normal documented procedures. Objective evidence will be maintained of the rework of the devices. For questions regarding this recall call 574-268-6379.
Quantity in commerce: 12 units
Distribution: Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.
Product codes and lots: Lot 009SV

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0934-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0934-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-06

Product code HWC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)