—#121220

Product

T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Spire Z Spinal System in conjunction with the set screwdriver to remove the implant during removal surgery. The set screw driver is attached to the end of the removal head and used to disengage the remaining portion of the set screw within the device.

FDA product code: HXX — Screwdriver
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: RS12K008

Why it was recalled

One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Medtronic sent an Urgent Voluntary Market Removal Recall letter dated August 9, 2013 with Recall Questionnaires and Confirmation forms included to Risk Managers and Sales Representatives. The letter identified the affected product, problem and action to be taken. Customers were instructed to remove the affected product, discontinue use and contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product. For questions call your Medtronic Sales Representative or Global Quality Department at 800-876-3133.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Place, Memphis, Tennessee 38132

Distribution

Distribution pattern: USA Nationwide Distribution in the state of GA, AK, WA, and CA.

Timeline

Recall initiated: 2013-08-12
Posted by FDA: 2013-09-14
Terminated: 2013-12-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121220. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.