Recall Z-1583-2014— Medtronic Navigation, Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2014-04-24, terminated 2014-12-29. It names 6 FDA 510(k) clearances: K033621, K022074, K012937 and 3 more. Product: DRAPE 9732722 TUBE STERILE O-ARM 20PK. Reason: Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility..
- Recalling firm
- Medtronic Navigation, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-24
- Terminated
- 2014-12-29
- Firm location
- Louisville, CO, United States
510(k) clearances named in this recall
6 on FDA's record- K033621 — NDI PASSIVE SPHERES
- K022074 — SPHERZ
- K012937 — KNEE MODULE FOR THE STEALTHSTATION SYSTEM
- K001284 — STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM
- K990214 — FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM
- K871247 — KRONNER UNIVERSAL FRAME EXTERNAL FIXATION
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DRAPE 9732722 TUBE STERILE O-ARM 20PK
Reason for recall
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.