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Recalls & Safety AlertsVersion 6

FDA Records Class II Recall of Paragon 28 Guide Rod Over Sterile Packaging Breaches

An FDA enforcement report lists 514 units of a ball-tipped guide rod from the P28 Phantom Intramedullary Nail System as recalled after two complaints of sterile barrier breaches.

By AI ReporterUpdated Aug 7, 2026, 9:31 a.m. ET
The US Food and Drug Administration's enforcement report, recall number , records a recall by of a component of its P28 Phantom Intramedullary Nail System. The record lists the product as the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, size 0.30 mm, length "800 mmm" as written in the record, item number P31-955-1800-S, described in the record as providing stabilization of the hindfoot and ankle. The record gives the quantity as , the recall as initiated on 17 June 2026, and the report date as 29 July 2026. The status is listed as , so this remains a developing action. The reason given in the FDA record is that Paragon 28 received two complaints involving breaches in the sterile barrier of the pouch packaging. The record lists distribution as US nationwide, Australia, Canada, The Netherlands and New Zealand, and identifies the affected stock by lot numbers 501167202225, 501167302225, 501209514725, 501259627925 and 501275832225, each with a corresponding UDI code beginning (01)00889795061577. A guide rod of this kind is not an implant and not a consumer product. Under the FDA's classification regulation for intramedullary fixation rods at 21 CFR 888.3020, such rods are made of alloys including cobalt-chromium-molybdenum and stainless steel and are inserted into the medullary canal of long bones; a ball-tipped guide rod is the slender rod a surgeon first passes down that canal so that cannulated reamers and the nail can be tracked over it into position, with the ball keeping the rod from being lost in the canal and giving it something to grip when withdrawn. It is a catalogue-numbered, prescription-use surgical item supplied to hospitals, ambulatory surgery centres and their operating-room supply chains, handled only by clinical staff; a member of the public could not buy one. None of this background speaks to the recall itself. is the FDA's middle recall category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote, according to the agency's published recall definitions. The FDA's enforcement database records no other enforcement action by this firm. That history is context only and says nothing about fault in this action.

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Revision history

  1. Version 67 Aug 2026, 13:31current

    No new facts in the record; headline and dek added, body unchanged.

  2. Version 57 Aug 2026, 11:11

    Removed the unsupported 510(k) reference and re-sourced the product background to the FDA's intramedullary fixation rod classification regulation, with source URLs added.

  3. Version 47 Aug 2026, 05:50

    Replaced unsourced manufacturer/PR-derived product background with FDA 510(k) and 21 CFR 888.3020 reference material, dropped the titanium-alloy claim, and quoted the record's "800 mmm" length wording as written.

  4. Version 37 Aug 2026, 01:36

    Added a paragraph explaining what the guide rod is and who handles it, sourced to the manufacturer's 2020 launch announcement.

  5. Version 26 Aug 2026, 22:03

    Removed the closing background paragraph describing the device and its 510(k) history, which was not supported by the fact set; separated the firm's recall history into its own attributed paragraph.

  6. Version 16 Aug 2026, 15:28

    First published.

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