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.

Read the official notice →
Date
2023-02-22
Country
United States
Brand
OrthoPediatrics
Product
Orthex Large Bone Shoulder Bolt, model no. AS-17
Classification
Class II
Units
Domestic distribution to Foreign distribution to
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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