Reported Jul 10, 2013 · Terminated

TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual…

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?

  • TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument
Lot codes and dates
    • 122518
    • 122447
Amount recalled
4

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, 5:35 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.