| Class 2 Device Recall LMP50 (Lesser Metatarsal Phalangeal Implant | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = KWH
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