Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Lagun
FDA device recall Z-1819-2008 · posted 2008-09-02 · Terminated
Recall details
- Recalling firm
- Allez Spine, LLC
- Reason for recall
- This field action was initiated because the cleaning, decontamination and sterilization procedures specified in the "Instructions for Use" for the impacted systems are incorrect. The use of these parameters in performing cleaning, decontamination and sterilization procedures may not result in clean and sterile product.
- Action taken
- Allez Spine issued a safety notice with attached fax-back attachment on April 14, 2008 via FedEx to all its hospital users, distributors and field representatives informing them of the failure of the sterilization validation and requesting them to use the new recommended sterilization parameters. The notice included copies of the updated Instructions for Use for the Allez Spine Laguna Pedicle Screw System and the Allez Spine Del Mar Pedicle Screw System. The safety notice requested that the revised recommended instructions be used for all future cleaning, decontamination and sterilization. Copies of the revised instructions were also provided with the safety notice along with links to the company website where additional copies may be downloaded. Contact Mark De Baca at 415-357-9908 if you have any questions.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 64 systems
- Distribution
- Nationwide to AZ, CA, CO, GA, IL, NV, TN, TX, UT
- Date initiated
- 2008-04-14
- Date posted
- 2008-09-02
- Date terminated
- 2010-01-25
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LAGUNA PEDICLE SCREW SYSTEM (K050060) | Allez Spine, LLC | 2005-05-04 |