Reported Jul 10, 2013 · Terminated

-Instratek Carpal Tunnel Release Blades, (1) Triangle Blade, (1) Hook Blade. REF R2056 - LOT 122279 -Instratek Carpal…

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?

11 of 11 products

Products covered by this recall
Model / numberProduct as published
R2056
LOT 122279 -Instratek Carpal Tunnel Release Hook Blade.
2055
Lot 122669 -Linvatec CTS Relief Kit.
9971
lot 122504 -Biomet Indiana Tome Blade for Carpal Tunnel Release (White).
200060.
Lot 122504 and
Lot 123190. -KMI SafeGuard Knife, For SafeGuard Mini Carpal Tunnel Release System, (White).
08-0003.
Lot # 122609 Surgical Knife
Lot codes and dates
    • 122279
    • 122493
    • 122504
    • 122609
    • 122669
    • 123190
Amount recalled
56 units

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, 4:51 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.