Reported Jun 25, 2014 · Terminated
EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use…
Biomet, 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: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- EZPass Nylon Monofilament Single Pack, Part number 110007379, Orthopedic Manual Surgical Instrument Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
- Lot codes and dates
- Part numbers 110007379 Lot 060830 and 258920,
- Amount recalled
- 100 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.
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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