Warsaw, IN, United States
OrthoPediatrics Corp recalls
7 recalls recorded since 2018, most recently on 12 September 2022. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)3
Terminated or completed4
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 12 September 2022
- Reason
- Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
- Distribution
- Domestic distribution to Foreign distribution to
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0277-2023
- Orthex Large Bone Shoulder Bolt, model no. AS-17
Ongoing Class II Medical devices
- Recall started
- 29 June 2022
- Reason
- Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of surgery and potentially damage soft tissue and increase healing time
- Distribution
- US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign: Australia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1678-2022
- Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Ongoing Class II Medical devices
- Recall started
- 6 July 2020
- Reason
- Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
- Distribution
- US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2742-2020
- Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct
Terminated Class II Medical devices
- Recall started
- 5 June 2020
- Terminated
- 25 May 2021
- Reason
- ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2539-2020, Z-2538-2020
- OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as A
- OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as A
Terminated Class II Medical devices
- Recall started
- 19 August 2019
- Terminated
- 30 April 2020
- Reason
- Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
- Distribution
- Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0219-2020, Z-0218-2020
- Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB
- Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The
Terminated Class II Medical devices
- Recall started
- 19 August 2019
- Terminated
- 26 October 2020
- Reason
- Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
- Distribution
- Nationwide Foreign: Australia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0125-2020
- OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixatio
Terminated Class II Medical devices
- Recall started
- 3 August 2017
- Terminated
- 8 May 2019
- Reason
- The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0597-2018
- Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.