Z-2173-2010

Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large...

Name: Z-2173-2010 Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large...
Creator: Sgarlato Med, LLC
Published: 2009-03-01
License: https://open.fda.gov/license/

Sgarlato Med, LLC / initiated 2009-03-01 / Terminated / root cause: labeling and UDI

FDA source

Sgarlato Med, LLC began a recall of Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA on 2009-03-01. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2173-2010
Status: Terminated
Initiated: 2009-03-01
Posted: 2010-08-04
Terminated: 2011-08-19
Recalling firm: Sgarlato Med, LLC
Product: Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA
Product code: KWH Prosthesis, Toe, Constrained, Polymer
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Recall initiated in March 2009 via telephone calls.
Quantity in commerce: 27 units
Distribution: Nationwide Distribution
Product codes and lots: Product expiration and lot number on the outer box lists: 2013/05 with lot number 051700. Inner package label states 2007/08 with lot number 091103a.

Product code KWH

K905795Class IISgarlato Flexible Hinge Toe ImplantSgarlato Laboratories, Inc. / cleared 1991-05-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)