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Terminated

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 fixation rod) Part number: 01-1503-0032

FDA Recall Z-0125-2020 · Posted None

Recalling FirmOrthoPediatrics Corp
Recall StatusTerminated
Product CodeHSB
Date Initiated2019-08-19
Date Terminated2020-10-26
Product Quantity211 units

Reason for Recall

Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures

Firm Action

OrthoPediatrics, Inc. notified Distributors by letter via email on 8/19/19 , stating reason for recall, health risk and action to take: Distributors have been instructed to review their inventory and the inventory at their clinical sites to recover the product. Questions contact: Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at [email protected] or 574-267-0897.

Root Cause

Device Design

Distribution Pattern

Nationwide Foreign: Australia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K172583OrthoPediatrics PediNail Intramedullary PlatformOrthopediatrics, Inc. · 2018-05-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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