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U.S. Department of Health and Human Services

Class 2 Device Recall Sgarlato Labs GAIT (Great Toe Implant Technique) Implant

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 Class 2 Device Recall Sgarlato Labs GAIT (Great Toe Implant Technique) Implantsee related information
Date Initiated by FirmMarch 01, 2009
Date PostedAugust 04, 2010
Recall Status1 Terminated 3 on August 19, 2011
Recall NumberZ-2173-2010
Recall Event ID 55775
510(K)NumberK905795 
Product Classification Toe Polymer Constrained Prosthesis - Product Code KWH
ProductSgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA
Code Information 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.
FEI Number 2939320
Recalling Firm/
Manufacturer		 Sgarlato Med, LLC
1975 Hamilton Ave Ste 38
San Jose CA 95125-5630
For Additional Information Contact
408-626-9600
Manufacturer 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.
FDA Determined
Cause 2		Labeling mix-ups
ActionRecall initiated in March 2009 via telephone calls.
Quantity in Commerce27 units
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KWH
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