FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
- Recall number
- Z-0849-2018
- Recalling firm
- DePuy Orthopaedics, Inc.
- Product
- Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
- Status
- Terminated
- Initiated
- 2017-07-26
- Posted
- not on file
- Terminated
- 2019-04-03
- Reason
- Potential for Intra-operative breakage of driver tips
- Root cause
- Under Investigation by firm
- Action
- On August 1, 2017, an Urgent Product Recall notice titled "CONCORDE LIFT DRIVER Driver Shaft and Torque Handle" was mailed to customers that received the affected instruments. The letter described the issue, potential hazard, and actions to be taken. The notice instructs customers to cease further distribution or use and to contact a DePuy Synthes Spine sales consultant to return the products subject to recall. Customers are to review, complete, sign, and return the business reply form provided to the firm within 5 business days of receipt of the notification. A copy of the notice should be forwarded to all staff that need to be informed, as well as, any facility that the affected device was further distributed to. Customers should direct any questions regarding this recall to their DePuy Synthes Spine Sales Consultant or the Clarke Madigan, DePuy Synthes Spine Recall Coordinator, at 508-828-609 or DPYUS-SpineFieldActions@its.jnj.com.
- Quantity
- 130 units total
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Product code: 287804102 Lot number: 122315-B R, 122315-A R, 041117A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1219655
- 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