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Terminated

Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.

FDA Recall Z-2067-2014 · Posted 2014-07-16

Recalling FirmInnovasis, Inc
Recall StatusTerminated
Product CodeNKB
Date Initiated2014-07-07
Date Terminated2014-08-11
Product Quantity32

Reason for Recall

Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.

Firm Action

Distributors were notified by e-mail on 7/7/14, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis. Distributors have been instructed to return all inventory in stock.

Root Cause

Process control

Distribution Pattern

Distribution US nationwide, including TX, CA, KS, MN, and OK. Foreign distribution to Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102248EXCELLA II SPINAL SYSTEM MODEL EC2-00Innovasis, Inc. · 2010-10-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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