—#161276

Product

Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.

FDA product code: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K171425
Affected lot / code info: Product code: 287804101G Lot number: 052316-A R, 121416-A R

Why it was recalled

Potential for Intra-operative breakage of driver tips

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 325 Paramount Dr, Raynham, Massachusetts 02767-5199

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2017-07-26
Terminated: 2019-04-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #161276. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.