Z-1535-2013Class II

90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole

Name: Z-1535-2013 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole
Creator: OrthoPediatrics Corp
Published: 2013-04-19
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2013-04-19 / Terminated / root cause: design

FDA source

OrthoPediatrics Corp began a recall of 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation... on 2013-04-19. FDA classified it as Class II and gives the reason as "Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1535-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-19
Posted: 2013-06-12
Terminated: 2013-09-19
Recalling firm: Orthopediatrics Corp
Product: 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.
Root cause tag: design
FDA root cause: Device Design
Action: OrthoPediatrics sent an Urgent Voluntary Recall notifiation via telephone and email to all affected consignees. The letter instructed consignees to take possession of any affected devices and quarantine immediately. A Mandatory Reply Form is included with the notification letter to be completed and returned. Please contact Greg Teghtmeyer if you have any questions (574-268-6379).
Quantity in commerce: 130 devices were shipped
Distribution: USA Nationwide Distribution
Product codes and lots: All lot numbers are affected. Catalog No. 00-1200-1001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1535-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1534-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-12
Z-1535-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-12
Z-1536-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-19	2013-06-12

Product code HWC

K110959Class IIOrthopediatrics Blade Plate SystemOrthoPediatrics Corp. / cleared 2011-08-05

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)