Recall Z-2173-2010 ยท KWH Prosthesis, Toe, Constrained, Polymer
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
| Date | Aug 4, 2010 (initiated Mar 1, 2009) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905795 | SGARLATO FLEXIBLE HINGE TOE IMPLANT Sgarlato Laboratories, Inc., May 29, 1991 |