Device recall: OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing…

Class II FDA enforcement event 67003. Recall start date: 7 Nov 2013. Status in the FDA record: Terminated. Termination date: 9 May 2014.

Reason for recall, in the words of FDA

Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

OrthoPediatrics Corp started this device recall on 7 Nov 2013. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 67003 has 1 product record. The first FDA enforcement report date is 1 Jan 2014. The record gives the status Terminated, with the termination date 9 May 2014.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution including the states of CA, KY, OH, RI, and TN.

Recalling firm

OrthoPediatrics Corp, Warsaw, IN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 67003: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0579-2014	OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.	40	Class II	Terminated	1 Jan 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class II: 90%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 21

Other events of the firm

Other FDA enforcement events of OrthoPediatrics Corp
Initiated	Product (first record)	Type	Class	Records
12 Sep 2022	Orthex Large Bone Shoulder Bolt, model no. AS-17	Device	Class II	1
29 Jun 2022	Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN	Device	Class II	1
6 Jul 2020	Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization	Device	Class II	1
5 Jun 2020	OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is	Device	Class II	2
19 Aug 2019	OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an	Device	Class II	1
19 Aug 2019	Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orth	Device	Class II	2
3 Aug 2017	Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation	Device	Class II	1
24 Apr 2017	Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon t	Device	Class II	1
18 Nov 2016	OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw	Device	Class III	1
27 Jul 2016	3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that of	Device	Class II	2

OrthoPediatrics Corp: all 21 events

Official channels

FDA enforcement report Z-0579-2014The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 67003. https://recallregister.com/fda/ii/67003/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
What quantity of product is in FDA event 67003?: The FDA record gives this quantity: 40
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 90% of the 1,236 device events that started in 2013 are in Class II.