Reported Sep 18, 2024 · Ongoing
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues.…
Smith & Nephew Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smith & Nephew Inc. · 150 Minuteman Rd · Andover, MA · 01810-1031
Is this the product you have?
- ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues
- Product Number2504-1
- Lot codes and dates
- UDI-DI00854501006067 Batch NumberBatch Number
5118005551180056511800575118005851180059511800605118006151180062511800635118006451180065511842805118428151184282511842835118428451184285511842865118428751184288511842895118429051185286511852875118528851185289
51185290511852915118529251185293511852945118529551185296511892475118924951189250511892515118925251189254511892555118925651189257511892585118925951193811511938165119381851193820
- UDI-DI00854501006067 Batch Number
- Amount recalled
- US: 6305 units; OUS : 160 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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