Z-0455-2010

Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc...

Name: Z-0455-2010 Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc...
Creator: Tornier, Inc.
Published: 2009-04-06
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2009-04-06 / Terminated / root cause: labeling and UDI

FDA source

Tornier, Inc. began a recall of Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc, Edina, MN 55435. The Lesser Metatarsal Phalangeal... on 2009-04-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0455-2010
Status: Terminated
Initiated: 2009-04-06
Posted: 2009-11-24
Terminated: 2011-12-17
Recalling firm: TORNIER Inc.
Product: 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.
Product code: KWH Prosthesis, Toe, Constrained, Polymer
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).
Root cause tag: labeling and UDI
FDA 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 in commerce: 77
Distribution: Worldwide Distribution -- USA, including states of CA, FL, MD, MI, NJ, OH, and PA, and country of France.
Product codes and lots: Lot number: K10747, K10677, and K10510.

Product code KWH

K023531Class IILesser Metatarsal Phalangeal Joint ImplantNexa Orthopedics, Inc. / cleared 2003-01-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)