Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO, , Manufactured by Tornier, Inc, Edina, MN 5
FDA device recall Z-0455-2010 · posted 2009-11-24 · Terminated
Recall details
- Recalling firm
- Tornier, Inc.
- 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).
- Action taken
- 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
- Status
- Terminated
- Product code
- KWH
- Quantity affected
- 77
- Distribution
- Worldwide Distribution -- USA, including states of CA, FL, MD, MI, NJ, OH, and PA, and country of France.
- Date initiated
- 2009-04-06
- Date posted
- 2009-11-24
- Date terminated
- 2011-12-17
- Location
- Edina, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LESSER METATARSAL PHALANGEAL JOINT IMPLANT (K023531) | Nexa Orthopedics, Inc. | 2003-01-17 |