FDA Medical Device Recalls (openFDA)
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 number
- Z-2173-2010
- 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
- Status
- Terminated
- Initiated
- 2009-03-01
- Posted
- 2010-08-04
- Terminated
- 2011-08-19
- Reason
- 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
- Labeling mix-ups
- Action
- Recall initiated in March 2009 via telephone calls.
- Quantity
- 27 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K905795"]
- PMA numbers
- not on file
- Product code
- KWH
- Firm FEI
- 2939320
- Firm city
- San Jose
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28