Reported Jul 10, 2013 · Terminated

- ConMed Linvatec Spectrum II Suture Hook Crescent, Medium (Teal) 4.0 x 20.0mm. REF C6386 Lot 122592. - Arthrex…

Surgical Instrument Service And Savings, 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: Surgical Instrument Service And Savings, Inc. · 2747 Sw 6th St · Redmond, OR · 97756-7109

Is this the product you have?

14 of 14 products

Products covered by this recall
Model / numberProduct as published
C6386
Lot 122592. - Arthrex SutureLasso SD, 25 Degree Tight Curve Left, Wire Loop, (Green) 1.8mm.
AR-4068-25TL
Lot 122518 and
Lot 123190. -- Arthrex SutureLasso SD, 25 Degree Tight Curve Right, w/Nitinol Wire Loop, (Lt. Green) 1.8mm.
AR-4068-25TR
Lot 122518 and
Lot 123190. - Arthrex SutureLasso SD, 90 Degrees (Black) 1.8mm.
AR-4068-90
Lot 122504. - Arthrex SutureLasso, 45 Degree, Perforating Needle Cannula, w/Suture Loop, (Lt. Grey).
AR-4065S
Lot 122590. -SutureLasso, w/Wire Loop, 90 Degree, (Blue)
AR-4065-90W
Lot 123263. Manual surgical instrument for general use
Lot codes and dates
    • 122504
    • 122518
    • 122504
    • 122590
    • 122592
    • 123190
    • 123263
Amount recalled
15

This recall covers 22 products

The agency filed one notice per product. You are reading one of them; the other 21 are below.

9 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 11, 2013 · Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.