Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine.
FDA Recall Z-0662-2016 · Posted 2016-01-19
Recalling FirmInnovasis, Inc
Recall StatusTerminated
Product CodeNKB
Date Initiated2015-12-07
Date Terminated2016-04-07
Product Quantity17 units Labeled SR55100 Lot 1502 with SR55110 rods in package
Reason for Recall
Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's labels.
Firm Action
Innovasis sent a Voluntary Product Recall letter, dated December 7, 2015 to customers regarding two lots of Excella II titanium rods which were packaged using each other's labels. Customers were asked to check their inventory and either remove the rod from the mislabeled package and request additional rods, or return the unopened packages immediately. The firm will replace all returned inventory upon receipt.
Root Cause
Labeling mix-ups
Distribution Pattern
Distributed in US -- CA; KS; OH; & TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.