FDA Medical Device Recalls (openFDA)
DePuy Spine, Inc.: DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
- Recall number
- Z-1670-2009
- Recalling firm
- DePuy Spine, Inc.
- Product
- DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300. Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
- Status
- Terminated
- Initiated
- 2009-02-11
- Posted
- 2009-08-14
- Terminated
- 2015-07-09
- Reason
- Tip of Driver may break during use
- Root cause
- Nonconforming Material/Component
- Action
- DePuy Spine notified direct accounts by visit and distributors by letter titled "Urgent - Voluntary Product Recall Notification". Accounts are requested to return the notification fax form and all affected product. For further questions, contact Depuy Spine at 1-800-227-6633.
- Quantity
- 117 units
- Distribution
- Nationwide Distribution -- Including states of MD, PA, NC, MO, NV, AZ, WI and CT.
- Lot, serial or model codes
- Product Code: 2894-10-300; Lot Number: 1208NT.
- 510(k) numbers
- ["K070300"]
- PMA numbers
- not on file
- Product code
- KWP
- Firm FEI
- 1526439
- Firm city
- Raynham
- Firm state
- MA
- 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