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.
FDA Recall Z-0455-2010 · Posted 2009-11-24
Recalling FirmTornier, Inc.
Recall StatusTerminated
Product CodeKWH
Date Initiated2009-04-06
Date Terminated2011-12-17
Product Quantity77
Reason for Recall
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).
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Worldwide Distribution -- USA, including states of CA, FL, MD, MI, NJ, OH, and PA, and country of France.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.