Reported Sep 25, 2013 · Terminated

Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or…

Implantech Associates 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: Implantech Associates Inc · 6025 Nicolle St Ste A · Ventura, CA · 93003-7602

Is this the product you have?

  • Device NameTerino Square Chin-Style II-Medium
  • Catalog NumberTSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region
Lot codes and dates
  • Catalog NumberTSCII-M
  • Lot Numbers848488 and 850156
Amount recalled
8

Where it was sold

Why it was recalled

Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M.

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 Feb 6, 2014 · Data as of Sep 19, 4:50 PM UTC

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