Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarla
FDA device recall Z-2173-2010 · posted 2010-08-04 · Terminated
Recall details
- Recalling firm
- Sgarlato Med, LLC
- 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.
- Action taken
- Recall initiated in March 2009 via telephone calls.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KWH
- Quantity affected
- 27 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-03-01
- Date posted
- 2010-08-04
- Date terminated
- 2011-08-19
- Location
- San Jose, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SGARLATO FLEXIBLE HINGE TOE IMPLANT (K905795) | Sgarlato Laboratories, Inc. | 1991-05-29 |