Stryker Corporation: STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Read the official notice at FDA (device) →
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 PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
- 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 07613327061352, Batch Numbers 24260FG2, 24261FG2, 24297FG2, 24298FG2, 24299FG2, 24302FG2, 24340FG2, 24341FG2, 25008FG2, 25009FG2, 25010FG2, 25011FG2, 25024FG2, 25034FG2, 25035FG2, 25052FG2, 25063FG2, 25064FG2, 25084FG2, 25092FG2, 25093FG2, 25121FG2, 25134FG2, 25135FG2, 25153FG2, 25154FG2, 25167FG2, 25182FG2, 25183FG2, 25216FG2, 25217FG2, 25245FG2, 25274FG2.
- Product quantity
- 11,857 Units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- San Jose
- State
- CA
- Country
- United States
- Event id
- 99340
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