Data Foundry

Medical device recalls 2022

HammerTube Implant — Class II medical device recall Z-1468-2022

Ongoing recall by Paragon 28, Inc., reported 2022-08-03, distributed nationwide. Due to Titanium plasma coating not present implant.

Recall numberZ-1468-2022
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmParagon 28, Inc., Englewood, CO, United States
Recall initiated2022-05-26
Classified2022-07-27
Reported by FDA2022-08-03
DistributedNationwide (US)
Quantity9 implants
UPC / GTIN / UDI-DI00889795033987
Lot numbers26010822202
Model numbersP40-002-0275-S

Product

HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)

Reason for recall

Due to Titanium plasma coating not present implant.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1468-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.