Paragon 28 Recalls Phantom Hindfoot Guide Rod (Z-2758-2026)
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Paragon 28, Inc. is recalling 514 units of the P28 PHANTON INTRAMEDULLARY NAIL SYSTEM Phantom Hindfoot TTC/TC Ball Tipped Guide Rod due to breaches in sterile barrier packaging.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-devices.
What Happened
Paragon 28, Inc. received two complaints involving breaches in the sterile barrier of the pouch packaging for the P28 PHANTON INTRAMEDULLARY NAIL SYSTEM Phantom Hindfoot TTC/TC Ball Tipped Guide Rod.
Which Products Are Affected
The recall affects the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, Item number P31-955-1800-S. Affected lots include: Lot Number 501167202225 (UDI (01)00889795061577(17)300122(10)501167202225); Lot Number 501167302225 (UDI (01)00889795061577(17)300122(10)501167302225); Lot Number 501209514725 (UDI (01)00889795061577(17)300527(10)501209514725); Lot Number 501259627925 (UDI (01)00889795061577(17)301006(10)501259627925); and Lot Number 501275832225 (UDI (01)00889795061577(17)301118(10)501275832225). A total of 514 units were distributed nationwide in the US as well as in Australia, Canada, The Netherlands, and New Zealand. The FDA recall number is Z-2758-2026 and the classification is Class II.
What You Should Do
Consumers and healthcare providers should follow instructions provided by Paragon 28, Inc. regarding the recalled devices.
Why This Matters
The recall addresses potential compromise of device sterility in a product used for stabilization of the hindfoot and ankle.
Source
FDA Recall Z-2758-2026 - Paragon 28, Inc., Englewood, CO
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,374 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.