Recall Z-0455-2010 ยท KWH Prosthesis, Toe, Constrained, Polymer
Tornier, Inc.
Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc, Edina, MN 55435. The Lesser Metatarsal Phalangeal Joint Implant is indicated for: Partial or complete dislocation of the lesser metatarsophalangeal joint.
| Date | Nov 24, 2009 (initiated Apr 6, 2009) |
| Status | Terminated |
| Reason | Tornier, Inc. has received a report of a mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier FGT-50 implant (Primus Flexible Great Toe Implant With Grommetts). |
| Root cause | Labeling mix-ups |
| Action | Consignees were sent on April 6, 2009 a Tornier "Urgent-Product Recall" letter dated April 3, 2009. The letter was addressed to Healthcare professionals and distributors. The letter described the problem and product involved. Advised consignees to immediately discontinue use of the affected product and to return any unused affected product to their facility. Advised their distributors to notify all accounts. They also attached a questionnaire needed for inventory status. |
| Quantity | 77 |
| Distribution | Worldwide Distribution -- USA, including states of CA, FL, MD, MI, NJ, OH, and PA, and country of France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023531 | LESSER METATARSAL PHALANGEAL JOINT IMPLANT Nexa Orthopedics, Inc., Jan 17, 2003 |