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Terminated

Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA

FDA Recall Z-2173-2010 · Posted 2010-08-04

Recalling FirmSgarlato Med, LLC
Recall StatusTerminated
Product CodeKWH
Date Initiated2009-03-01
Date Terminated2011-08-19
Product Quantity27 units

Reason for Recall

Products with an expiration date of August, 2009 were labeled with an expiration date of May 2013. Additionally, the outer packages were labeled with an incorrect lot number. The outer and inner packages did not match.

Firm Action

Recall initiated in March 2009 via telephone calls.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K905795SGARLATO FLEXIBLE HINGE TOE IMPLANTSgarlato Laboratories, Inc. · 1991-05-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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