FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of degenerative Spondylolisthesis.
- Recall number
- Z-1554-05
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of degenerative Spondylolisthesis.
- Status
- Terminated
- Initiated
- 2005-05-16
- Posted
- 2005-09-21
- Terminated
- 2005-12-02
- Reason
- The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence.
- Root cause
- Other
- Action
- The notification letters and product accountability forms were sent to their branches/agencies and the one hospital via Fedex on 5/16/2005 with return receipt.
- Quantity
- 107
- Distribution
- Stryker distributes their product though branches/agencies and occassionally directly to hospitals. These branches/agencies are located nationwide and will deliver the device to the medical facility. There are 31 branches and 1 hospital involved.
- Lot, serial or model codes
- Catalog No: 48905110 Lot Code: 039524; 039981; 045152; 045153; 045154; 045155; 045156; 045157; 045158; 045159; 048721; 048722.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MNH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- 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