Recall Z-1593-2014— 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: PIN, 9733236, 150MM, STERILE, PERC REF. 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
PIN, 9733236, 150MM, STERILE, PERC REF
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.