FDA Medical Device Recalls (openFDA)
Stryker Spine: The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW Manufactured by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000. The system is intended for posterior, non-cervical pedicle and non-pedicle pedicle fixation of the spine. It is indicated for: degenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion.
- Recall number
- Z-2235-2012
- Recalling firm
- Stryker Spine
- Product
- The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW Manufactured by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000. The system is intended for posterior, non-cervical pedicle and non-pedicle pedicle fixation of the spine. It is indicated for: degenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion.
- Status
- Terminated
- Initiated
- 2012-04-25
- Posted
- 2012-08-22
- Terminated
- 2013-02-27
- Reason
- The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery.
- Root cause
- Labeling mix-ups
- Action
- Stryker sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter to affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was attached for customers to complete and return via fax to 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this notice.
- Quantity
- 40 units.
- Distribution
- Distributed in Atlanta, Georgia.
- Lot, serial or model codes
- Code information listed in the following format: Manufacturer Part Number/Prodcut Description/Corresponding IFU Part Number/Affected Lot #s are as follows: 48900445/Trio Standard Post Screw 5.5x55mm/#NOLI135B03Rev02/57281 and 57201 48900450/Trio Standard Post Screw 5.5x60mm/#NOLI135B03Rev02/57197 48900455/Trio Standard Post Screw 4.5x45mm/#NOLI135B03Rev02/57198 48900555/Trio Standard Post Screw 4.5x50mm/#NOLI135B03Rev02/56599 48900560/Trio Standard Post Screw 4.5x55mm/#NOLI135B03Rev02/57192
- 510(k) numbers
- ["K062698"]
- PMA numbers
- not on file
- Product code
- MNI
- Firm FEI
- 3004024955
- Firm city
- Allendale
- Firm state
- NJ
- 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