OrthoPediatrics recalls

2 official recalls and safety alerts involving OrthoPediatrics since 2022-09, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with OrthoPediatrics or the relevant agency.

1. 2023-02-22
2. US
   Drugs & medicalClass II

   OrthoPediatrics Corp recalls Orthex Large Bone Shoulder Bolt, model no. AS-17

   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.

   FDA · DeviceOrthoPediatrics CorpDomestic distribution to Foreign distribution toOfficial notice →
3. 2022-09-14
4. US
   Drugs & medicalClass II

   OrthoPediatrics Corp recalls Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN

   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…

   FDA · DeviceOrthoPediatrics CorpUS Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign:…Official notice →