UnratedMedical device recall · FDA · Published May 26, 2022
Paragon 2: HammerTube Implant Recall Due to Missing Titanium Coating
Paragon 28 recalls HammerTube Implant 2.75mm cannulated (sterile) due to missing titanium coating. Affected units have specific part numbers and lot numbers. Consumers should contact for details.
“Paragon 2: HammerTube Implant Recall Due to Missing Titanium Coating.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60580-paragon-2-hammertube-implant-recall-due-to-missing-titanium-coating. Based on FDA recall #Z-1468-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1468-2022%22&limit=1).
The FDA announced on May 26, 2022, that Paragon 28, Inc. is recalling HammerTube Implants due to a missing titanium plasma coating. The agency issued recall number Z-1468-2022 for the Class II device.
The recall is due to the titanium plasma coating not being present on the implant. The FDA stated this defect characterizes the product.
Context
GovInfoNow's records show Paragon 28, Inc. has 9 other recalls on record since December 19, 2017. Other recent recalls of similar products include Straumann Custom Abutment Ti Recall (March 17, 2026) and Arrowhead Implant Recall (June 23, 2026).
How to tell if you have this one
Check for part number P40-002-0275-S and lot number 26010822202 on the implant packaging or label. The implant is sterile and cannulated.
Reach out to Paragon 28 directly for specific guidance on affected units and next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Georgia, Illinois, Kentucky.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1468-2022 (May 26, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1468-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.