Sgarlato Med, LLC Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA
Brand
Sgarlato Med, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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.
Sgarlato Med, LLC is recalling Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Ma due to Products with an expiration date of August, 2009 were labeled with an expiration date of May 2013. Additionally, the outer packages were labeled with . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Recall initiated in March 2009 via telephone calls.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026