FDA Medical Device Recalls (openFDA)
Allez Spine, LLC: Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2 (Part Number: 54004)
- Recall number
- Z-1819-2008
- Recalling firm
- Allez Spine, LLC
- Product
- Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2 (Part Number: 54004)
- Status
- Terminated
- Initiated
- 2008-04-14
- Posted
- 2008-09-02
- Terminated
- 2010-01-25
- Reason
- 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.
- Root cause
- Error in labeling
- Action
- 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.
- Quantity
- 64 systems
- Distribution
- Nationwide to AZ, CA, CO, GA, IL, NV, TN, TX, UT
- Lot, serial or model codes
- Serial /System Numbers: 002, 003, 004, 005, 006, 007, 008, 009, 010, 012, 013, 014, 015, 017, 019, 020, 021, 023, 024, 025, 029, 030, 031, 032, 034, 035, 036, 038, 039, 040, 041, 042, 043, 044, 045, 048, 049, 050, 051, 053, 054, 055, 056, 057, 059, 060, 061, 062, 063, 064, 065, 066, 067, 068, 069, 070, 071, 072, 073, 074, 076, 077, 079, 080
- 510(k) numbers
- ["K050060"]
- PMA numbers
- not on file
- Product code
- MNI
- Firm FEI
- 3005032381
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28