T8 REMOVAL HEAD, REF 8910641, QTY: 1 EA, Product Usage: The non-sterile T8 Removal Diriver is used with the Spire and Sp

FDA device recall Z-2200-2013 · posted 2013-09-14 · Terminated

Recall details

Recalling firm

Medtronic Sofamor Danek USA Inc

Reason for recall

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HXX

Quantity affected

9 units

Distribution

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

Date initiated

2013-08-12

Date posted

2013-09-14

Date terminated

2013-12-27

Location

Memphis, TN