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Stryker Corporation: STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640

Medical DevicesSource: FDA (device) · Date: 2026-08-12

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Stryker Corporation
Product
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
Reason / hazard
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Recall initiated
2026-06-08
Code info
GTIN 07613327061475, Batch Number: 24284FG2, 24289FG2, 24313FG2, 24322FG2, 24338FG2, 24344FG2, 24351FG2, 25009FG2, 25036FG2, 25062FG2, 25091FG2, 25129FG2, 25161FG2.
Product quantity
2,739 of units
Voluntary mandated
Voluntary: Firm initiated
City
San Jose
State
CA
Country
United States
Event id
99340
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