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U.S. Department of Health and Human Services

Class 2 Device Recall LMP50 (Lesser Metatarsal Phalangeal Implant

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  Class 2 Device Recall LMP50 (Lesser Metatarsal Phalangeal Implant see related information
Date Initiated by Firm April 06, 2009
Date Posted November 24, 2009
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-0455-2010
Recall Event ID 52886
510(K)Number K023531  
Product Classification Toe Polymer Constrained Prosthesis - Product Code KWH
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.
Code Information Lot number: K10747, K10677, and K10510.
Recalling Firm/
Manufacturer
Tornier, Inc.
3601 W 76th Street, Suite 200
Edina MN 92121-1204
For Additional Information Contact
858-866-0660
Manufacturer 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).
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KWH and Original Applicant = NEXA ORTHOPEDICS, INC.
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